Prophylactic corticosteroids for cardiopulmonary bypass in adults

Stefan JM Dieleman; J van Klarenbosch

doi:10.1002/14651858.CD005566

Prophylactic corticosteroids for cardiopulmonary bypass in adults

Authors' declarations of interest

Version published: 25 January 2006 Version history

https://doi.org/10.1002/14651858.CD005566

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

Our primary interest is the effect of corticosteroid use for cardiopulmonary bypass on a composite end‐point of mortality, myocardial infarction and pulmonary complications (including pulmonary oedema and/or infection) at 30 days of follow‐up. In addition, the effect of corticosteroids on the separate components of the primary outcome and other complications, including prolonged mechanical ventilation and stroke, will be assessed. There are no restrictions with respect to length of the follow‐up period. Selected studies qualify for pooling of results for one or more time‐points.

Background

Description of the condition
The development of cardiopulmonary bypass (CPB) in the early 1950s has been a breakthrough in cardiac surgery. The possibility of temporary suppression of cardiac activity while maintaining systemic circulation with a heart‐lung machine, allowed surgical instrumentation of a non‐beating heart. Patients with coronary vessel or heart valve disease could from then on be treated with an effective relief of symptoms and prolonged life expectancy. However, it gradually became clear that CPB can have deleterious effects on the patient. Extracorporeal circulation induces a complex inflammatory reaction, often resulting in a systemic inflammatory response syndrome (SIRS), a sepsis like condition. Patients with SIRS require prolonged treatment in the postoperative intensive care unit and are probably at a higher risk for major complications.

CPB sets in motion an extremely complex and multifaceted response. Shortly, this response involves complement activation, along with activation of platelets, neutrophils, monocytes, and macrophages. As a result, coagulation and fibrinolytic cascades are initiated. The ensuing SIRS is associated with fever, impaired alveolar gas exchange, vasodilatation, myocardial stunning, renal insufficiency and even multiorgan dysfunction (Asimakopoulos 1999; Moat 1993; Roach 1996; Zanardo 1994). It is conceivable that SIRS contributes to the incidence of major complications after heart surgery, including death, myocardial infarction, and loss of renal function. In the past decades, several studies have evaluated the association between SIRS and major complications after heart surgery. But due to limited power, this relationship has not been established so far (Fillinger 2002; Kilger 2003; McBride 2004; Tassani 1999; Toft 1997; Turkoz 2001).

Description of the intervention
Because SIRS is associated with a variety of clinical symptoms possibly leading to major complications, it seems reasonable to attenuate this response with anti‐inflammatory agents. Typically, a single dose of dexamethasone or methylprednisolone is therefore injected intravenously before commencing CPB. These corticosteroids are potent anti‐inflammatory agents that possess multi‐inhibitory effects on numerous components of the inflammatory response, and therefore represent an appealing treatment option in this scenario (Chaney 2002; Hill 1998; Wan 1997a). However, the use of corticosteroids has important potential disadvantages as well. It has been demonstrated that the use of corticosteroids is associated with inadequate glucose control, higher lactate levels, a higher sensitivity to infectious agents, impaired wound healing and gastrointestinal blood loss. Some of these complications could lead to prolonged intensive care stay and increased morbidity and mortality (Van den Berghe 2001).

Why it is important to do this review
A substantial number of trials have been conducted comparing heart surgery with and without corticosteroid use. Most trials focused on intermediate, non‐clinical end‐points like serum markers and pulmonary water content, demonstrating a significant suppression of inflammation (Andersen 1989; Anic 2004; Boldt 1986; Boscoe 1983; Busto 1979; Celik 2004; Corbi 2001; Engelman 1995; Ferries 1984; Fosse 1987; Harig 1999; Hill 1994; Jansen 1991; Jorens 1993; Karlstad 1993; Kawamura 1995; Kawamura 1999; Loubser 1997; Mayumi 1997; Nuutinen 1976; Tabardel 1996 ;Tassani 1999; Tennenberg 1986; Teoh 1995; Toft 1997; Wan 1997b; Wan 1999). Only a limited number of trials evaluated clinical end‐points after corticosteroid administration, and these studies show conflicting results.(Chaney 1998; Chaney 1999a; Chaney 1999b; Chaney 2001; Coffin 1975; Fecht 1978; Fillinger 2002; Heikkinen 1985; Kilger 2003; Loef 2004; Mangos 1995; Miranda 1982; Morton 1976; Niazi 1979; Oliver 2004; Rao 1977; Toft 1997; Toledo‐Pereyra 1980; Von Spiegel 2002; Yared 1998). To date, none of the trials have had enough power (less than 100 patients per group) to demonstrate an obvious clinical benefit that is relevant to the patients themselves.

Nowadays, the use of corticosteroids in heart surgery is almost standard care in several European countries, while in the United States less than 20% of all centers for cardiac surgery use corticosteroids in the perioperative period. There is no consensus as to whether the potential benefits of corticosteroid use outweigh their possible disadvantages. This results in major disagreement regarding corticosteroid usage between centres, and even between physicians within one hospital, while there is no convincing evidence available on this subject (Chaney 2002). Facing the lack of evidence from a sufficiently powered trial, we initiated this systematic review and meta‐analysis of the currently available studies comparing cardiac surgery with and without the perioperative use of corticosteroids.

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials

Types of participants

Adults (= 18 years or more):

diagnosed with coronary artery disease (CAD) or coronary valve disease;
candidate for on‐pump isolated bypass surgery, valve replacement surgery or ventricle or atrial septum defect surgery.

Types of interventions

Cardiac surgery with cardiopulmonary bypass with or without perioperative corticosteroid administration.

Types of outcome measures

Primary outcomes
Composite end‐point, consisting of the following:

Mortality;
Myocardial infarction;
Pulmonary complications (including pulmonary oedema and/or infection).

Secondary outcomes

Pulmonary complications (including pulmonary oedema and/or infection);
Prolonged mechanical ventilation;
Stroke;
Length of postoperative stay in ICU;
Postoperative transfusion requirement;
Postoperative inotropes use;
Postoperative infection;
Wound infection;
Sternal dehiscence;
Other intermediate pathophysiological outcomes.

Search methods for identification of studies

We will search CENTRAL on The Cochrane Library, PubMed, EMBASE, CINAHL and Web of Science (SCI/SSCI) using relevant search terms relating to heart surgery procedures with cardiopulmonary bypass and corticosteroids. To retrieve all randomised trials these search terms will be combined with a sensitive methodological filter for randomised trials. The strategy for searching CENTRAL is below, see additional tables 01 to 04 for details of other strategies (Table 1 Table 2; Table 3; Table 4).

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Table 1. Search strategy: Medline (PubMed) 1966 to 2005

("Steroids"[mh:noexp] OR "Adrenal Cortex Hormones"[mh:noexp] OR "Anti‐Inflammatory Agents"[mh]) OR (steroid* [tiab] OR steriod* [tiab] OR predniso* [tiab] OR methylpredniso* [tiab] OR dexamethasone [tiab] OR glucocortico* [tiab] OR hydrocortiso* [tiab])

AND

(("Cardiac surgical procedures"[mh] OR "coronary artery bypass"[tiab] OR "cardiac surgery"[tiab] OR "thoracic surgery"[tiab]) OR ("Extracorporeal Circulation"[mh] OR "Heart‐Lung Machine"[mh] OR "cardiopulmonary bypass"[tiab] OR "extracorporeal circulation"[tiab] OR "heart‐lung machine"[tiab] OR "heart lung machine"[tiab] OR "cpb"[tiab]))

AND

(((((meta‐analysis [pt] OR meta‐analysis [tw] OR metanalysis [tw]) OR ((review [pt] OR guideline [pt] OR consensus [ti] OR guideline* [ti] OR literature [ti] OR overview [ti] OR review [ti]) AND ((Cochrane [tw] OR Medline [tw] OR CINAHL [tw] OR (National [tw] AND Library [tw])) OR (handsearch* [tw] OR search* [tw] OR searching [tw]) AND (hand [tw] OR manual [tw] OR electronic [tw] OR bibliographi* [tw] OR database* OR (Cochrane [tw] OR Medline [tw] OR CINAHL [tw] OR (National [tw] AND Library [tw]))))) OR ((synthesis [ti] OR overview [ti] OR review [ti] OR survey [ti]) AND (systematic [ti] OR critical [ti] OR methodologic [ti] OR quantitative [ti] OR qualitative [ti] OR literature [ti] OR evidence [ti] OR evidence‐based [ti]))) BUTNOT (case* [ti] OR report [ti] OR editorial [pt] OR comment [pt] OR letter [pt]) OR (randomized controlled trial[PTYP] OR randomized controlled trials OR controlled clinical trial[PTYP] OR clinical trial[PTYP] OR clinical trials OR (clinical AND trial) OR random allocation OR random* OR double blind method OR single blind method OR (singl* OR doubl* OR trebl* OR tripl*) OR blind* OR mask* OR placebo* OR placebos OR research design OR comparative study OR evaluation studies OR follow up studies OR prospective studies OR control OR controlled OR prospectiv* OR volunteer*)) OR (random* OR randomized controlled trial* OR Randomized Controlled Trial [PT]) NOT (letter [pt] OR editorial [pt] OR comment [pt] OR in vitro [mh]) OR (randomized controlled trial [PTYP] OR drug therapy [SH] OR therapeutic use [SH:NOEXP] OR random* [WORD]))) NOT ("animals"[MeSH Terms] NOT ("humans"[MeSH Terms] OR "hominidae"[MeSH Terms]))

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Table 2. Search strategy: Embase (Embase.com) 1989 to 2005

'human'/exp

AND

('corticosteroid'/exp OR 'antiinflammatory agent'/exp OR 'steroid':ti,ab OR 'steroids':ti,ab OR 'dexamethasone':ti,ab OR 'prednisone':ti,ab OR 'prednisolone':ti,ab OR 'methylprednisolone':ti,ab OR 'steriod':ti,ab OR 'steriods':ti,ab)

AND

(('heart surgery'/exp OR 'heart surgery':ti,ab OR 'heart‐surgery':ti,ab OR 'open heart surgery':ti,ab OR 'coronary surgery':ti,ab OR 'coronary artery surgery':ti,ab OR 'coronary artery bypass surgery':ti,ab OR 'cabg':ti,ab OR 'coronary artery bypass graft':ti,ab OR 'coronary bypass graft':ti,ab OR 'coronary bypass graft surgery':ti,ab OR 'heart valve surgery':ti,ab) OR ('extracorporeal circulation'/exp OR 'cardiopulmonary bypass':ti,ab OR 'cpb':ti,ab OR 'extracorporeal circulation':ti,ab OR 'ecc':ti,ab))

AND

(random$:ti,ab OR factorial$:ti,ab OR (crossover$ or cross over$ or cross‐over$):ti,ab OR placebo$:ti,ab OR (doubl$ adj blind$):ti,ab OR (singl$ adj blind$):ti,ab OR assign$:ti,ab OR allocat$:ti,ab OR volunteer$:ti,ab OR (CROSSOVER PROCEDURE):sh OR (DOUBLE‐BLIND PROCEDURE):sh OR (RANDOMIZED CONTROLLED TRIAL):sh OR (SINGLE‐BLIND PROCEDURE):sh)

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Table 3. Search strategy: ISI Web of Science Science (SCI & SSCI) 1988 to 2005

TS=(steroid* OR corticosteroid* OR dexamethasone OR prednisone OR prednisolone OR methylprednisolone OR steriod* OR antiinflammatory agent)

AND

TS=((cardiopulmonary bypass OR cpb OR extracorporeal circulation OR ecc) OR (heart surgery OR heart‐surgery OR open heart surgery OR coronary surgery OR coronary artery surgery OR coronary artery bypass surgery OR cabg OR coronary artery bypass graft OR coronary bypass graft OR coronary bypass graft surgery OR heart valve surgery))

AND

TS=(metaanalysis OR meta‐analysis OR review OR consensus OR guideline OR random* OR trial* OR control* OR ((singl* OR doubl* OR trebl* OR tripl*) AND (blind* OR mask*)))

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Table 4. Search strategy: CINAHL (Ovid WebSpirs) 1982 to 2005

((explode "Steroids‐" / all TOPICAL SUBHEADINGS / all AGE SUBHEADINGS in DE) OR ((steroid* OR corticosteroid* OR dexamethasone OR prednisone OR prednisolone OR methylprednisolone OR steriod* OR antiinflammatory agent) in de,ti,ab))

AND

(((explode "Extracorporeal‐Circulation" / all TOPICAL SUBHEADINGS / all AGE SUBHEADINGS in DE)) OR ((cardiopulmonary bypass OR cpb OR extracorporeal circulation OR ecc) in de,ti,ab)) AND (("Heart‐Surgery" / all TOPICAL SUBHEADINGS / all AGE SUBHEADINGS in DE) OR ((heart surgery OR heart‐surgery OR open heart surgery OR coronary surgery OR coronary artery surgery OR coronary artery bypass surgery OR cabg OR coronary artery bypass graft OR coronary bypass graft OR coronary bypass graft surgery OR heart valve surgery) in de,ti,ab))

AND

((explode "Clinical‐Trials" / all TOPICAL SUBHEADINGS / all AGE SUBHEADINGS in DE) OR ((Randomized controlled trial OR clinical trial* OR clinical‐trial* OR control* OR prospectiv* OR volunteer* OR ((singl* OR doubl* OR trebl* OR tripl*) AND (blind* OR mask*)) OR placebo* OR random* OR evaluation studies OR prospective study) in de,ti,ab))

Reference lists from retrieved randomised trials, meta‐analyses and systematic reviews will be screened to identify additional trials. Related Articles identified by PubMed will be screened. Careful records will be kept from every step during searching and a QUOROM statement will be completed. No language restrictions will be applied.

CENTRAL (on The Cochrane Library); issue 3/2005
#1 STEROIDS
#2 ANTI‐INFLAMMATORY AGENTS
#3 steroid*
#4 dexamethasone
#5 predniso*
#6 methylpredniso*
#7 glucocortico*
#8 hydrocortiso*
#9 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8)
#10 EXTRACORPOREAL CIRCULATION
#11 (cardiopulmonary next bypass)
#12 (extracorporeal next circulation)
#13 HEART‐LUNG MACHINE
#14 (heart next lung next machine)
#15 cpb
#16 CARDIAC SURGICAL PROCEDURES
#17 (coronary near bypass)
#18 (heart next bypass)
#19 (heart near bypass)
#20 (cardiac next bypass)
#21 (cardiac near bypass)
#22 (cardiac next surgery)
#23 (heart next surgery)
#24 (open next heart)
#25 (#10 or #11 or #12 or #13 or #14 or #15)
#26 (#16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24)
#27 (#25 or #26)
#28 (#9 and #27)

Data collection and analysis

Criteria for inclusion and exclusion of studies

Studies should be clinical (human) and in adult subjects (= 18 years of age).
Trial participants are patients diagnosed with coronary artery disease (CAD) or coronary valve disease.
Trial participants are patients undergoing bypass surgery and/or valve replacement surgery.
Treatment allocation is based on randomisation.
No restrictions will be applied with respect to language.

Selection of studies

First phase: each title found will be independently judged by two reviewers (a resident in anesthesiology and an epidemiologist). If both are certain that a study is unsuitable, based on the title, this study will be excluded. The abstracts of all other titles will be printed.
Second phase: based on the abstract the remaining titles will be independently judged by the two reviewers. If both are certain that a study is unsuitable, based on its abstract, this study will be excluded. The complete text of all other titles will be printed.
Third phase: based on the complete article the remaining titles will be independently judged by the two reviewers. If both are certain that a study is unsuitable, this study will be excluded. The exclusion will be motivated briefly on the selection form. If their opinion is split, the article will be discussed until consensus achieved, if necessary with help a third researcher (anaesthesiologist).

For each title, abstract or full‐text article a standardized selection form was used to assess study eligibility (Table 5), will be used. The reviewers will not be blinded for authors' names or journal names.

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Table 5. Study eligibility form

Questions	Responses
Study ID
Publication date
Source	Medline	Embase	Web of Science	CINAHL	Other:
Name of reviewer	Dieleman	Van Dijk	Van Klarenbosch
Selection criteria:
* Randomised clinical trial	Yes	No	Not known
* Reporting mortality or AMI or pulmonary complications	Yes	No	Not known
* Adult population (>= 18 years of age)	Yes	No	Not known
‐> Conclusion (I) (based on TITLE only; to be filled in if abstract is not available)	not eligible	may be eligible
‐‐> Conclusion (II) (based on ABSTRACT)	not eligible	may be eligible
‐‐‐> Conclusion (III) (based on WHOLE ARTICLE)	not eligible	eligible for review
Motivation (if necessary)

All included studies will be thoroughly studied by the two reviewers and data recorded into a data extraction form (Table 6).

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Table 6. Data extraction form

Questions	Responses
ARTICLE IDENTIFICATION	Article nr.:	...........................	Date:	....../....../...........
Name of reviewer:	Dieleman	Van Dijk	Van Klarenbosch
First author's name:
Year of publication:
STUDY CHARACTERISTICS
1. Total number of patients included	Steroids	n =
	Control	n =
2. Randomized allocation	Yes	No	Unclear
3. Concealed allocation	Yes	No	Unclear
4. Number of crossovers	Steroids	n =
	Control	n =
5. Maximum number of loss‐to‐follow‐up (at any stage)	Steroids	n =
	Control	n =
6. Intention to treat analyses	Yes	No	Unclear
7. Blinding during pre‐, peri‐ and postoperative care	Yes	No	Unclear
8. Blinded data‐collection and analyses	Yes	No	Unclear
9. Standardized pre‐ and postoperative care	Yes	No	Unclear
10. Blinding of endpoints	Yes	No	Unclear
11. Standardization of endpoints	Yes	No	Unclear
PREOPERATIVE DATA
12. Males (males/total)	Steroids	n = ...... / ......
	Control	n = ...... / ......
13. Age	Steroids	Mean =	SD =
	Control	Mean =	SD =
14. Body Mass Index	Steroids	Mean =	SD =
	Control	Mean =	SD =
15. Prior cardiac surgery	Steroids	n = ...... / ......
	Control	n = ...... / ......
16. Preoperative cardiac status	NYHA‐classification	Type 1	Type 2	Type 3	Type 4
	Steroids	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
	Control	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
	Braunwald‐classification	Type 1	Type 2	Type 3	Type 4
	Steroids	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
	Control	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
17. Preoperative atrial fibrillation	Steroids	n = ...... / ......
	Control	n = ...... / ......
18. Preoperative myocardial infarction	Steroids	n = ...... / ......
	Control	n = ...... / ......
19. Preoperative beta‐blocker use	Steroids	n = ...... / ......
	Control	n = ...... / ......
20. Hypertension	Steroids	n = ...... / ......
	Control	n = ...... / ......
21. Diabetic status	Steroids	n = ...... / ......
	Control	n = ...... / ......
22. Renal status (dialysis)	Steroids	n = ...... / ......
	Control	n = ...... / ......
23. Type of steroid used	Dexamethasone	Methylprednisolone	Other: .......................................
24. Dose of steroid used	......
25. Time of administration	Before induction	After induction	While on CPB	After CPB	......
26. Preoperative steroid use	Steroids	n = ...... / ......
	Control	n = ...... / ......
27. Type(s) of surgery		Steroids	Control
	CABG	n = ...... / ......	n = ...... / ......
	VR	n = ...... / ......	n = ...... / ......
	Combined CABG + VR	n = ...... / ......	n = ...... / ......
	Other	n = ...... / ......	n = ...... / ......
28. Duration of procedure	Steroids	Mean =	SD =
	Control	Mean =	SD =
29. Duration of CPB	Steroids	Mean =	SD =
	Control	Mean =	SD =
30. Primary outcome measure:	..............................................
31. Main outcomes	Steroids (n of mean)	Steroids (n‐total of SD)	Control (n or mean)	Control (n‐total or SD)	Time to follow‐up (days)
Mortality (n)	......	......	......	......	......
AMI (n)	......	......	......	......	......
Pulmonary complications:
‐ ............................................................................ (n)	......	......	......	......	......
‐ ............................................................................ (n)	......	......	......	......	......
Duration of postoperative ventilation (min; mean + SD)	......	......	......	......
Length of stay in ICU (hrs; mean + SD)	......	......	......	......
Postoperative transfusion requirement (n)	......	......	......	......	......
Postoperative inotrope use (n)	......	......	......	......	......
32. Main conclusions	...............................................
	...............................................
	...............................................
33. Remarks	...............................................
	...............................................
	...............................................
	...............................................
	...............................................

Assessment of methodological quality of included studies
Criteria for assessing the quality of the studies (see Table 6, items 2, 3, 5, 7, 8 and 10):

concealed treatment allocation;
standardized post‐surgical care;
blinded outcome assessment (for other endpoints than mortality);
attrition (missing data, notably due to loss‐to follow‐up);
deviation from allocated treatment (treatment drop‐out [full or partial] and treatment cross‐over);
intention to treat analysis.

Based on these criteria, studies will be subdivided into the following three categories:
A ‐ all quality criteria met: low risk of bias;
B ‐ one or more of the quality criteria only partly met: moderate risk of bias;
C ‐ one or more criteria not met: high risk of bias.

Data extraction (Table 6)

Baseline characteristics: gender, age, body mass index, prior cardiac surgery, preoperative parameters (e.g. cardiac status, atrial fibrillation, myocardial infarction, beta blocker use, hypertension, diabetes, dialysis, corticosteroid usage).
Outcome measures: type of surgery, duration of procedure/CPB, type and dose of corticosteroid (dose expressed as amount of hydrocortisone equivalents), time point of administration, mortality, acute myocardial infarction, pulmonary complications (including pulmonary oedema, atelectasis and/or infection), stroke, duration of postoperative ventilation, length of stay in ICU, postoperative transfusion/inotropes requirement.

Statistical methods
We will calculate event rates per treatment group for the combined endpoints, by dividing the number of events by the number of patients allocated. For continuous variables, weighted means will be calculated according to the number of patients in the study. This is done according to the intention to treat principle, in which patients are analysed according to randomised allocation. Odds Ratios (OR) are derived from these event rates. For trials without events in one or both groups, the OR is zero and the standard error cannot be calculated. To deal with this problem we will add the conventional 0.5 to each cell in the contingency table of these trials.

Because trials found may not have been carried out according to a common protocol there will usually be variations in patient groups, clinical settings, concomitant care, etc. Although some differences in treatment effect are to be expected, if it is greater than that expected by chance, it will be important to consider if it is still appropriate to pool data. Therefore we plan to assess homogeneity of trial data by using the I‐square test of heterogeneity. Trial data will be considered to be heterogeneous if P < 0.10. If significant heterogeneity is present, an attempt will be made to explain the differences based on the patient clinical characteristics and interventions of the included studies. In addition, an odds ratio will be calculated using the conservative, random effects method. If heterogeneity is removed using this method it will be considered safe to pool the data.

Differences in quality of study methods will be taken into account in a sensitivity analysis. Additionally, we will explore the influence of individual quality criteria in a sensitivity analysis.

The following variables will be considered for meta‐regression:

Age;
Diabetes;
NYHA‐classification / Braunwald classification (unstable angina);
Type of surgery;
Study quality;
Dose of corticosteroid (expressed as equivalent hydrocortisone dose).

In addition we will use age, study quality and dose for exploring effects in subgroups.

Table 1. Search strategy: Medline (PubMed) 1966 to 2005

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Table 2. Search strategy: Embase (Embase.com) 1989 to 2005

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Table 3. Search strategy: ISI Web of Science Science (SCI & SSCI) 1988 to 2005

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Table 4. Search strategy: CINAHL (Ovid WebSpirs) 1982 to 2005

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Table 5. Study eligibility form

Questions	Responses
Study ID
Publication date
Source	Medline	Embase	Web of Science	CINAHL	Other:
Name of reviewer	Dieleman	Van Dijk	Van Klarenbosch
Selection criteria:
* Randomised clinical trial	Yes	No	Not known
* Reporting mortality or AMI or pulmonary complications	Yes	No	Not known
* Adult population (>= 18 years of age)	Yes	No	Not known
‐> Conclusion (I) (based on TITLE only; to be filled in if abstract is not available)	not eligible	may be eligible
‐‐> Conclusion (II) (based on ABSTRACT)	not eligible	may be eligible
‐‐‐> Conclusion (III) (based on WHOLE ARTICLE)	not eligible	eligible for review
Motivation (if necessary)

Table 5. Study eligibility form

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Table 6. Data extraction form

Questions	Responses
ARTICLE IDENTIFICATION	Article nr.:	...........................	Date:	....../....../...........
Name of reviewer:	Dieleman	Van Dijk	Van Klarenbosch
First author's name:
Year of publication:
STUDY CHARACTERISTICS
1. Total number of patients included	Steroids	n =
	Control	n =
2. Randomized allocation	Yes	No	Unclear
3. Concealed allocation	Yes	No	Unclear
4. Number of crossovers	Steroids	n =
	Control	n =
5. Maximum number of loss‐to‐follow‐up (at any stage)	Steroids	n =
	Control	n =
6. Intention to treat analyses	Yes	No	Unclear
7. Blinding during pre‐, peri‐ and postoperative care	Yes	No	Unclear
8. Blinded data‐collection and analyses	Yes	No	Unclear
9. Standardized pre‐ and postoperative care	Yes	No	Unclear
10. Blinding of endpoints	Yes	No	Unclear
11. Standardization of endpoints	Yes	No	Unclear
PREOPERATIVE DATA
12. Males (males/total)	Steroids	n = ...... / ......
	Control	n = ...... / ......
13. Age	Steroids	Mean =	SD =
	Control	Mean =	SD =
14. Body Mass Index	Steroids	Mean =	SD =
	Control	Mean =	SD =
15. Prior cardiac surgery	Steroids	n = ...... / ......
	Control	n = ...... / ......
16. Preoperative cardiac status	NYHA‐classification	Type 1	Type 2	Type 3	Type 4
	Steroids	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
	Control	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
	Braunwald‐classification	Type 1	Type 2	Type 3	Type 4
	Steroids	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
	Control	n = ...... / ......	n = ...... / ......	n = ...... / ......	n = ...... / ......
17. Preoperative atrial fibrillation	Steroids	n = ...... / ......
	Control	n = ...... / ......
18. Preoperative myocardial infarction	Steroids	n = ...... / ......
	Control	n = ...... / ......
19. Preoperative beta‐blocker use	Steroids	n = ...... / ......
	Control	n = ...... / ......
20. Hypertension	Steroids	n = ...... / ......
	Control	n = ...... / ......
21. Diabetic status	Steroids	n = ...... / ......
	Control	n = ...... / ......
22. Renal status (dialysis)	Steroids	n = ...... / ......
	Control	n = ...... / ......
23. Type of steroid used	Dexamethasone	Methylprednisolone	Other: .......................................
24. Dose of steroid used	......
25. Time of administration	Before induction	After induction	While on CPB	After CPB	......
26. Preoperative steroid use	Steroids	n = ...... / ......
	Control	n = ...... / ......
27. Type(s) of surgery		Steroids	Control
	CABG	n = ...... / ......	n = ...... / ......
	VR	n = ...... / ......	n = ...... / ......
	Combined CABG + VR	n = ...... / ......	n = ...... / ......
	Other	n = ...... / ......	n = ...... / ......
28. Duration of procedure	Steroids	Mean =	SD =
	Control	Mean =	SD =
29. Duration of CPB	Steroids	Mean =	SD =
	Control	Mean =	SD =
30. Primary outcome measure:	..............................................
31. Main outcomes	Steroids (n of mean)	Steroids (n‐total of SD)	Control (n or mean)	Control (n‐total or SD)	Time to follow‐up (days)
Mortality (n)	......	......	......	......	......
AMI (n)	......	......	......	......	......
Pulmonary complications:
‐ ............................................................................ (n)	......	......	......	......	......
‐ ............................................................................ (n)	......	......	......	......	......
Duration of postoperative ventilation (min; mean + SD)	......	......	......	......
Length of stay in ICU (hrs; mean + SD)	......	......	......	......
Postoperative transfusion requirement (n)	......	......	......	......	......
Postoperative inotrope use (n)	......	......	......	......	......
32. Main conclusions	...............................................
	...............................................
	...............................................
33. Remarks	...............................................
	...............................................
	...............................................
	...............................................
	...............................................

Table 6. Data extraction form

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Prophylactic corticosteroids for cardiopulmonary bypass in adults

Abstract

Visual summary

Background

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Search methods for identification of studies

Data collection and analysis

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Abstract

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Background

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Search methods for identification of studies

Data collection and analysis

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