Inclusion and definition of acute renal dysfunction in critically ill patients in randomized controlled trials: a systematic review

Abstract

BackgroundIn evidence-based medicine, multicenter, prospective, randomized controlled trials (RCTs) are the gold standard for evaluating treatment benefits and ensuring the effectiveness of interventions. Patient-centered outcomes, such as mortality, are most often the preferred evaluated outcomes. While there is currently agreement on how to classify renal dysfunction in critically ill patients , the application frequency of this new classification system in RCTs has not previously been evaluated. In this study, we aim to assess the definition of renal dysfunction in multicenter RCTs involving critically ill patients that included mortality as a primary endpoint.MethodsA comprehensive search was conducted for publications reporting multicenter randomized controlled trials (RCTs) involving adult patients in intensive care units (ICUs) that included mortality as a primary outcome. MEDLINE and PUBMED were queried for relevant articles in core clinical journals published between May 2004 and December 2017.ResultsOf 418 articles reviewed, 46 multicenter RCTs with a primary endpoint related to mortality were included. Thirty-six (78.3%) of the trial reports provided information on renal function in the participants. Only seven articles (15.2%) included mean or median serum creatinine levels, mean creatinine clearance or estimated glomerular filtration rates. Sequential organ failure assessment (SOFA) score was the most commonly used definition of renal dysfunction (20 studies; 43.5%). Risk, Injury, Failure, Loss, End-stage renal disease (RIFLE), Acute Kidney Injury Network (AKIN) and Kidney Disease Improving Global Outcomes (KDIGO) criteria were used in five (10.9%) trials. In thirteen trials (28.3%), no renal dysfunction criteria were reported. Only one trial excluded patients with renal dysfunction, and it used urinary output or need for renal replacement therapy (RRT) as criteria for this diagnosis.ConclusionThe presence of renal dysfunction was included as a baseline patient characteristic in most RCTs. The RIFLE, AKIN and KDIGO classification systems were infrequently used; renal dysfunction was generally defined using the SOFA score.

The Role of RIFLE, AKIN and KDIGO Criteria in Determining the Relationship Between Acute Kidney Injury and Mortality in Intensive Care Patients

“…The reported incidence of AKI in patients followed in the intensive care unit is between 20% and 50%, and this rate exceeds 70% in the presence of sepsis. A mortality rate of 15-70% has been reported in this group [1][2][3][4] . The lack of consensus on the definition of AKI and the presence of different definitions over 35 currently in use are likely reasons for the large variability in reported frequency and mortality rates.…”

Effect of Angiotensin‐Converting Enzyme Inhibitors/Angiotensin Receptor Blockers on In‐Hospital Outcomes Based on Renal Function Among Critically Ill Patients: Findings From the Medical Information Mart for Intensive Care IV Database

“…Critically ill patients with renal dysfunction are associated with prolonged LOS in the hospital and ICU, increased hospitalization costs, and progression to CKD 12 . Renal dysfunction is more common in critically ill patients.…”

“…Critically ill patients with renal dysfunction are associated with prolonged LOS in the hospital and ICU, increased hospitalization costs, and progression to CKD. 12 Renal dysfunction is more common in critically ill patients. ACEI/ARB has been used extensively in patients with renal dysfunction, cardiovascular diseases, and so on.…”

Identification of Subclasses of Decompensated Cirrhotic Patients with Acute Kidney Injury with Different Responses to Fluid Input

“…AKI was divided into stage 1 (elevation of creatinine level: <2 times the baseline value), stage 2 (2 or 3 times), and stage 3 (>3 times). For patients who did not have an available SCr value prior to hospitalization, we used the first measured value during hospitalization as the baseline SCr [18, 19].…”