Elsevier

Journal of Critical Care

Volume 44, April 2018, Pages 337-344
Journal of Critical Care

Renal
Pragmatic studies for acute kidney injury: Consensus report of the Acute Disease Quality Initiative (ADQI) 19 Workgroup

https://doi.org/10.1016/j.jcrc.2017.12.006Get rights and content

Highlights

  • Important gaps in existing knowledge for acute kidney injury were identified.

  • Pragmatic studies were proposed in several distinct areas.

  • A two-step process in order to inform as to current practice is involved.

Abstract

Purpose

Acute kidney injury (AKI) has become a major medical and financial burden in China along with the rest of the world. There have been considerable advances in the understanding of the epidemiology and pathogenesis of AKI. However, there is no consensus regarding the optimal care for patients. The Acute Disease Quality Initiative (ADQI) 19 meeting focused on identifying and designing relevant and achievable AKI-related studies in China.

Materials & methods

The working group developed a list of preliminary questions and objectives and performed analysis of the existing literature. Relevant studies were identified through a literature search using the MEDLINE database and bibliographies of relevant research and review articles. We then used a two-step Delphi process to prioritize a research agenda and proposed specific study designs to address unmet needs.

Results

Important gaps in existing knowledge were identified and pragmatic studies were proposed in three distinct areas: care bundles for AKI prevention, renal replacement therapy (RRT) for AKI, and fluid management. In addition, the use of biomarkers to guide clinical trials was discussed.

Conclusions

Consensus was reached on a research agenda for AKI with a specific focus on pragmatic trials in China.

Introduction

Acute kidney injury (AKI) is a common problem in the intensive care unit (ICU), and is associated with increased mortality and high healthcare costs. However, information regarding the optimal care of patients with AKI is limited and there are numerous unanswered questions in the management of AKI during critical illness. Pragmatic trials with a focus on AKI could provide a path to better understanding of different aspects of AKI management. In particular, the questions of how to prevent AKI using care bundles, how to prescribe intravenous fluids in patients with or at risk for AKI, how to manage patients requiring renal replacement therapy (RRT) in the ICU and how to employ AKI biomarkers to improve outcomes in real world clinical settings could all be the subject of pragmatic trials. However, the best design for such studies requires detailed knowledge of existing practices to establish feasibility, equipoise, and sample-size. China, with its large population and rapidly increasing standard of medical care, is particularly burdened by the financial impact of AKI. Furthermore, with its large hospitals China is well-suited for pragmatic trials.

In a recent prospective, multicenter, cross-sectional survey of hospitalized adult patients in China, only 1–2% of hospitalized patients are diagnosed with AKI, corresponding to 1.4 to 2.9 million cases per annum [1]. Given that AKI are reported at nearly 10 times higher rates in many countries [2], China can expect to see its rates soar as recognition of AKI increases. In Chinese ICUs, rates of AKI have been reported to range from 32% to 51%, with an in-hospital mortality rate of up to 46% [3], [4], [5]—much more consistent with other countries [6]. Available evidence suggests that 20–25% of patients with AKI in ICUs in China are treated with RRT [3], [4], [5], almost exclusively with continuous modalities. As the prevalence and outcomes of AKI and RRT in Chinese ICUs appear comparable to those reported in North America and Europe, the results of pragmatic trials in China could be generalizable to other developed and developing countries.

In order to address the potential for the most feasible pragmatic trial design, we convened a two-day meeting (ADQI 19 consensus conference titled “Pragmatic Studies for AKI”) in Wuhan, China on April 3–4, 2017. In this report, we summarize the recommendations of the group and supporting evidence. We also discuss the gaps in our knowledge to identify future research directions.

Section snippets

Methods

The aims of 19th ADQI Consensus Conference were: i. to develop recommendations for the design and conduct of relevant and feasible studies in the field of critical care nephrology that could be carried out in China; and ii. to generate robust evidence informing management of AKI both in China and globally. The recommendations include the questions to be addressed in pragmatic trials and the suggested format of these trials. To achieve these goals the 19th ADQI Chairs empaneled a diverse group

Topic 1: care bundles for AKI prevention

The care of hospitalized patients with AKI has been shown to be very variable in routine clinical practice [7], [8], [9], [10], [11], [12]. Systematic tools, including simple checklists, care bundles, and medical algorithms have been proposed and tested to improve the quality of care and patient outcomes. Although compliance with AKI bundles is generally low in routine clinical practice, when mandated or tested in clinical studies, utilization of these tools often leads to better outcomes as

Conclusions

The 19th International ADQI conference successfully reached consensus on a number of novel pragmatic trials to address gaps in knowledge for China and the world. The proposed trials were two-step designs. In the first step, prospective observational studies are conducted to better understand and document current practice. In some cases practice variation is embraced so as to find practices that are associated with best outcomes. In other cases, standardization is sought through checklists and

Conflicts of interests

Dr. Kellum discloses grant support and consulting fees from Astute Medical, Bard, Baxter, Bioporto, and NxStage. Dr. Ronco discloses speaker and consulting fees from Astute, ASAHI, GE, Toray, Baxter, Medtronic and OCD. Dr. Murugan discloses grant support from National Institute of Health, La Jolla Inc., Bioporto Inc., and consulting fees from Beckman Coulter Inc. Dr. Kashani received research funds from ASTUTE medical Inc. Dr. Prowle reports receiving speaker fees and travel from Baxter Inc.

Acknowledgements

We would like to extend our sincere thanks to the Chinese Society of Critical Care Medicine (Dr. Kaijiang Yu) and Zhongnan Hospital of Wuhan University (Dr. Zhiyong Peng) for organizing this ADQI. We'd like to express our appreciation to Mayo Clinics (Dr. Kianoush Kashani) for revising figures and Ms. Qin Xie for writing assistance with this manuscript.

Funding

This work was supported by the National Natural Science Foundation of China (ZP, 81560131) and Hubei Key Projects (ZP, WJ2017Z008).

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