REVERSE-AKI Randomized Controlled Pilot Trial

NCT03251131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-12-14

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03251131 on ClinicalTrials.gov