REVERSE-AKI Randomized Controlled Pilot Trial
NCT03251131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-12-14
Summary
Observational studies among patients with acute kidney injury (AKI) have shown an association with fluid accumulation and increased mortality. Trials among other subgroups of critically ill patients have demonstrated that restricting fluid input after the initial resuscitation appears safe.
The objective if this study is to determine whether a fluid restrictive treatment regimen will lead to a lower cumulative fluid balance at 72 hours from randomization in critically ill patients with AKI and whether this approach is safe and feasible.
Conditions
- Acute Kidney Injury
- Critical Illness
Interventions
- OTHER
-
Restrictive fluid management
Daily fluid input is restricted to drugs and nutrition. Fluid boluses and blood products can be given if clinically indicated. Matching fluid output to fluid input whenever possible using diuretics if needed, and additionally, if clinically necessary and plausible, commencing renal replacement therapy. If renal replacement therapy is not deemed clinically desirable, acceptance of a less than targeted fluid balance.
Sponsors & Collaborators
-
Austin Hospital, Melbourne Australia
collaborator OTHER -
Guy's and St Thomas' NHS Foundation Trust
collaborator OTHER -
University Hospital, Ghent
collaborator OTHER -
Medical University Innsbruck
collaborator OTHER -
University of Lausanne Hospitals
collaborator OTHER -
Helsinki University Central Hospital
lead OTHER
Principal Investigators
-
Suvi Vaara, MD, PhD · Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
-
Marlies Ostermann, MD, PhD · Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-08
- Primary Completion
- 2020-01-31
- Completion
- 2020-04-30
Countries
- Australia
- Belgium
- Finland
- Switzerland
- United Kingdom
Study Locations
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