Loop diuretics in adult intensive care patients with fluid overload: A protocol for a systematic review of randomised clinical trials with meta‐analysis and Trial Sequential Analysis

Abstract

Background In the intensive care unit, fluid overload is frequent and a risk factor for organ dysfunction and increased mortality. Primarily, lung and kidney functions may be impaired by fluid overload resulting in acute respiratory failure and acute kidney injury. No clinical guidelines exist for treatment of fluid overload in intensive care patients. Loop diuretics, most often furosemide, appear to be the most frequently used pharmacological intervention. The aim of this protocol is to describe the methods of a systematic review assessing the evidence of treatment with loop diuretics in adult intensive care patients with fluid overload. Methods We will conduct a systematic review with meta‐analysis and report it according to Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) Statements, use the recommendations of the Cochrane Handbook and assess the quality of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. We will include randomised clinical trials identified through searches of major international databases and trial registers. Two authors will independently screen and select trials for inclusion, extract data and assess the methodological quality using the Cochrane risk of bias tool. Extracted data will be analysed using Review Manager and Trial Sequential Analysis. The protocol is registered at PROSPERO. Discussion We aim to provide reliable evidence on the use of loop diuretics in adult intensive care patients with fluid overload to guide clinicians, decision makers and trialists on clinical practice.

Loop diuretics in adult intensive care patients with fluid overload: a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

“…This systematic review was conducted according to our published protocol and statistical analysis plan [ 26 ]. The protocol was registered in the International Register of Systematic Reviews Database PROSPERO (CRD42020184799).…”

“…(4) Higher-dose loop diuretic compared with lower dose loop diuretic. We accepted any dose, formulation, timing, and duration of intervention [ 26 ].…”

“…Ongoing and unpublished trials were searched from databases of clinical trial registries and United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) [ 26 ].…”

“…(4) Outcomes: specified primary, secondary, and explorative outcomes. (5) Trial funding and notable conflicts of interest [ 26 ].…”

“…No systematic reviews have assessed the benefits and harms of loop diuretics in the treatment of fluid overload in the ICU and no guidelines exist. With the present systematic review, our primary aim is to assess the existing evidence on all-cause mortality, quality of life, and serious adverse events from randomised clinical trials (RCT) on the treatment of fluid overload with loop diuretics in adult ICU patients [ 26 ].…”