REVERSE-AKI Randomized Controlled Pilot Trial (REVERSE-AKI)

December 10, 2020 updated by: Suvi Vaara, Helsinki University Central Hospital

REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Acute kidney injury (AKI) is common in the critically ill and associates with adverse outcomes. Patients with AKI are frequently have low urine output and are at high risk of developing fluid overload. Fluid overload has been associated with an increased risk for mortality in such patients. Previous trials in critically ill patients found that a 'restrictive fluid therapy' after resuscitation was safe. Implementing a restrictive fluid therapy approach in patients with AKI may also be of benefit. To date, however, no randomized trial has been performed to evaluate the safety and feasibility of implementing a 'restrictive fluid therapy' approach compared to standard fluid therapy in patients with AKI.

In this pilot randomized controlled trial we will evaluate the implementation of a fluid restrictive approach, compared to standard therapy, in adult critically ill patients with acute kidney injury.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Canberra, Australia
        • Canberra Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3048
        • Austin Hospital
      • Ghent, Belgium
        • Ghent University Hospital
      • Helsinki, Finland
        • Helsinki University Hospital
      • Lausanne, Switzerland
        • Lausanne University Hospital
      • London, United Kingdom
        • Royal London Hospital, Barts Health NHS Trust
      • London, United Kingdom
        • Guy's and St Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-years or older and admitted to critical care with an arterial line in place
  2. The patient has been in critical care for at least 12 hours but no more than 72 hours
  3. The patient has AKI but is not receiving acute RRT:

    For the purpose of the study AKI is defined the by the following criteria:

    1. Increase in serum creatinine over 1.5-times above baseline without a decline of 27umol/l or more from the last preceding measurement (at least 12 hours apart) AND/OR
    2. Overall urine output less than 0.5ml/kg/h (or 6ml/kg) for the previous 12h (with urine catheter in place for the period)
  4. The patient is judged by the treating clinician not to be intravascularly hypovolemic
  5. The patient is likely to remain in critical care for 48 hours after randomization

Exclusion Criteria:

  1. Active bleeding necessitating transfusion
  2. Maintenance fluid therapy is necessary due to diabetic ketoacidosis, non-ketotic coma, severe burns or other clinical reason determined by the medical staff
  3. Need for RRT due to intoxication of a dialyzable toxin
  4. Commencement of RRT is expected in the next 6 hours
  5. On chronic renal replacement therapy (maintenance dialysis or renal transplant)
  6. Presence or a strong clinical suspicion of parenchymal AKI (for example glomerulonephritis, vasculitis, acute interstitial nephritis), or post-renal obstruction
  7. Severe hyponatremia (Na <125mmol/L) or hypernatremia (Na >155mmol/L)
  8. Need for extracorporeal membrane oxygenation or molecular absorbent recirculating system (MARS-therapy)
  9. Pregnant or lactating
  10. Patients who are not to receive full active treatment
  11. No baseline creatinine available
  12. Lack of consent
  13. The patient has been enrolled in another trial where co-enrollment is not feasible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restrictive fluid management
Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.
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.
No Intervention: Standard therapy
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative fluid balance
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of acute kidney injury
Time Frame: ICU discharge/14 days
Defined according to Kidney Disease: Improving Global Outcomes criteria
ICU discharge/14 days
Number of patients requiring renal replacement therapy
Time Frame: 14 days
14 days
Cumulative fluid balance
Time Frame: 24 hours
24 hours
Cumulative fluid balance
Time Frame: ICU discharge/ 7 days
ICU discharge/ 7 days
Cumulative dose of diuretics
Time Frame: ICU discharge/ 7 days
ICU discharge/ 7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 90 days
90 days
Number of patients with serious adverse events and reactions
Time Frame: 7 days

a Ventricular tachycardia/fibrillation b. New onset of atrial fibrillation requiring medication/defibrillation c. Ischemic events i. Acute myocardial infarction ii. Cerebral ischemia verified by CT or MRI scan.

iii. Intestinal ischemia verified by endoscopy or open surgery.

iv. Acute peripheral limb ischemia d. Radiologically diagnosed pulmonary edema e. Adverse events related to renal replacement therapy and diuretics use f. Frequency of hypokalaemia (serum K <3.5mmol/L) g. Frequency of hypomagnesaemia (serum Mg <0.8mmol/L) h. frequency of serum pH >7.5 i. other

7 days
Mechanical ventilation free days alive
Time Frame: 14 days
14 days
Vasopressor free days and alive
Time Frame: 14 days
14 days
Renal replacement therapy free days and alive
Time Frame: 90 days
90 days
Dialysis dependence
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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
  • Principal Investigator: Marlies Ostermann, MD, PhD, Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2017

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

August 12, 2017

First Submitted That Met QC Criteria

August 12, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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