The implementation of a nutrition protocol in a surgical intensive care unit; a randomized controlled trial at a tertiary care hospital

Background Malnutrition in critically ill patients is linked with significant mortality and morbidity. However, it remains controversial whether nutrition therapy protocols are effective in improving clinical outcomes. The present study aimed to evaluate the effectiveness of a surgical ICU nutrition protocol, and to compare the hospital mortality, hospital LOS, and ICU LOS of protocol and non-protocol groups. Methods A randomized controlled trial was conducted at the Surgical ICU, Siriraj Hospital. The nutrition administration of the control group was at the discretion of the attending physicians, whereas that of the intervention group followed the “Siriraj Surgical ICU Nutrition Protocol”. Details of the demographic data, nutritional data, and clinical outcomes were collected. Results In all, 170 patients underwent randomization, with 85 individuals each in the protocol and non-protocol groups. More than 90% of the patients in both groups were at risk of malnutrition, indicated by a score of ≥ 3 on the Nutritional Risk Screening 2002 tool. The average daily calories of the 2 groups were very similar (protocol group, 775.4±342.2 kcal vs. control group, 773.0±391.9 kcal; p = 0.972). However, the median time to commence enteral nutrition was shorter for the protocol group (1.94 days) than the control group (2.25 days; p = 0.503). Enteral nutrition was provided within the first 48 hours to 53.7% of the protocol patients vs. 47.4% of the control patients (p = 0.589). In addition, a higher proportion of the protocol patients (36.5%) reached the 60% calorie-target on Day 4 after admission than that for the non-protocol group (25.9%; p = 0.136). All other clinical outcomes and nutrition-related complications were not significantly different. Conclusions The implementation of the nutrition protocol did not improve the feeding effectiveness or clinical outcomes as compared to usual nutrition management practices of the Surgical ICU.


Objectives
1. To develop a nutrition protocol in surgical Intensive Care Unit Siriraj hospital. 2. To compare the effectiveness of the nutrition therapy and clinical outcomes between the patients whose nutrition therapy are managed by the nutritional protocol group and the patients whose therapy are followed by the judgement of attending physicians (control group).
Inclusion: Adult critically ill surgical patients who are admitted to SICUs and expected to stay in the ICUs longer than 2 days. 3. The time to start feeding, the percentage of patients who received EN within the first 48 hours, the total daily calories received, and the proportion of patients receiving > 60% of the target calories on Day 4 of their ICU admission. 4. The percentage of patients who had hyper/hypoglycemia, vomiting, aspiration, abdominal distention, or a gastric residual volume > 250 ml. 5. ICU mortality rate, the in-hospital mortality rate, the ICU/hospital LOS, the duration of mechanical ventilation, and the incidence of new infections developed in the ICU.

Surgical ICU Nutrition protocol
After enrollment, the baseline characteristics and nutritional status data were collected. The NRS-2002 and MUST scores were used to evaluate the baseline nutritional data, while the NUTRIC score was subsequently calculated to determine the need for supplemental parenteral nutrition (SPN). In the case of the protocol group, the 100%-target calories were defined as 30 kcal per kg of predicted body weight. The Siriraj SICU Nutrition Protocol (Diagram 1) was started with EN within 24 hours (with the permission of the surgeons), provided there were no contraindications (such as active shock with high-dose vasopressor; tolerating an adequate oral diet, or requiring less than 24 hours to begin an oral diet; and receiving palliative care). The acceptable surgical conditions for which EN was not allowed to commence within 24 hours are detailed in Diagram 1; those conditions were re-assessed with the surgeons every 12 hours. Although total PN might be considered for those conditions, the patients were still re-assessed for EN eligibility every 12 hours. EN was commenced with a full-strength (1:1) polymeric formula. The goal was 80% of the target calories within 72 hours. A prokinetic agent was administered if that goal was not achieved; alternatively, postpyloric feeding might be considered on a case-by-case basis. In the event that the total daily calorie intake was still < 60% of the target on Day 4 of admission, a patient's NUTRIC score would then be redetermined and the SPN Protocol would be observed (Diagram 2). If the NUTRIC score was > 5, partial PN was initiated to reach the 100% calorie-target. On the other hand, if the NUTRIC score was < 5, the EN was continued until Day 8. Partial PN was then commenced if the calories from the EN were still < 60% of the target. The management of gastrointestinal intolerance is illustrated in Diagram 3. week? 4. Is the patient severely ill? (e.g. in intensive therapy) YES: If the answer is 'Yes' to any question, the screening in table 2 is performed NO: If the answer is 'No' to all questions, the patient is re-screened at weekly intervals. If the patient e.g. is scheduled for a major operation, a preventive nutritional care plan is considered to avoid the associated risk status. Wt loss >5% in 1 months (>15% in 3 months) or BMI <18.5 + impaired general condition or Food intake < 0-25% of normal requirement in preceding week

Score 3
Head injury Bone marrow transplantation Intensive care patients (APACHE>10) Total SCORE  (if age ≥ 70 add 1 score) =  Score 3: the patient is nutritionally at-risk and a nutritional care plan is initiated Score <3: weekly rescreening of the patient. If the patient eg. Is scheduled for a major operation, a preventive nutritional care plan is considered to avoid the associated risk status

Sample size calculation
To compare efficacy of nutrition administration protocols in SICU, follow to the information of old ICU Database we prognose that number of patient that met 100% target calories in control group is 50% and 75% in protocol group with statistical significant.
The output of the sample size calculation from n4Studies: for a randomized controlled trial with binary outcome. (7)(8)(9) Formula for RCT binary data without continuity correction Formula for RCT binary data with continuity correction P control = Number of surgical critically ill patient in Siriraj SICU that met 100% target calories in control group is 50% P treatment = Number of surgical critically ill patient in Siriraj SICU that met 100% target calories in treatment group is 75% P(outcome|treatment) = 0.750 P(outcome|control) = 0.500 Ratio (control/treatment) = 1.00 Alpha (α) = 0.05, Z(0.975) = 1.959964 Beta (β) = 0.10, Z(0.900) = 1.281552 So the sample size in treatments group = 77, controls group = 77 and calculated sample size by using a continuity correction treatments group = 85 and controls group= 85 Randomized population by "Block of Four" technique Primary outcome: Efficacy of nutrition therapy provided by the SICUs compared with the non-nutrition protocol.
Secondary outcomes: ICU and hospital mortality, Hospital and ICU length of stay.
Statistical analysis of the data -Continuous variables were expressed as means±SD or median with interquartile range (IQR). -Categorical variables were compared using the x 2 test or fisher's exact test, as appropriate. -Group comparisons were performed by using the independent Student's t-test, Mann-Whitney U test, chi-squared test, or Fisher's exact test, as appropriate. A two-sided alpha level of 0.05 was required for statistical significance. The data were analyzed by using the Statistical Package for Social Sciences for Windows, version 18 (SPSS Inc., Chicago, IL, USA)