REVERSE-AKI Randomized Controlled Pilot Trial

NCT03251131 | Completed Phase 2

• 1 other identifier: HUS/1782/2017
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cumulative fluid balance

  72 hours

Secondary Outcomes (5)

• Duration of acute kidney injury

  ICU discharge/14 days

• Number of patients requiring renal replacement therapy

  14 days

• Cumulative fluid balance

  24 hours

• Cumulative fluid balance

  ICU discharge/ 7 days

• Cumulative dose of diuretics

  ICU discharge/ 7 days

Other Outcomes (6)

• Number of patients with serious adverse events and reactions

  7 days

• Mechanical ventilation free days alive

  14 days

• Vasopressor free days and alive

  14 days

Study Arms (2)

Restrictive fluid management

EXPERIMENTAL

Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.

Other: Restrictive fluid management

Standard therapy

NO INTERVENTION

Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.

Interventions

Restrictive fluid management OTHER

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.

Restrictive fluid management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older and admitted to critical care with an arterial line in place
• The patient has been in critical care for at least 12 hours but no more than 72 hours
• The patient has AKI but is not receiving acute RRT:
• For the purpose of the study AKI is defined the by the following criteria:
• 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
• Overall urine output less than 0.5ml/kg/h (or 6ml/kg) for the previous 12h (with urine catheter in place for the period)
• The patient is judged by the treating clinician not to be intravascularly hypovolemic
• The patient is likely to remain in critical care for 48 hours after randomization

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Austin Hospital, Melbourne Australia: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• University Hospital, Ghent: collaborator
• Medical University Innsbruck: collaborator
• University of Lausanne Hospitals: collaborator

Study Sites (7)

Austin Hospital

Melbourne, Victoria, 3048, Australia

Location

Canberra Hospital

Canberra, Australia

Location

Ghent University Hospital

Ghent, Belgium

Location

Helsinki University Hospital

Helsinki, Finland

Location

Lausanne University Hospital

Lausanne, Switzerland

Location

Guy's and St Thomas Hospital

London, United Kingdom

Location

Royal London Hospital, Barts Health NHS Trust

London, United Kingdom

Location

Related Publications (1)

• Vaara ST, Ostermann M, Selander T, Bitker L, Schneider A, Poli E, Hoste E, Joannidis M, Zarbock A, van Haren F, Prowle J, Pettila V, Bellomo R. Protocol and statistical analysis plan for the REstricted fluid therapy VERsus Standard trEatment in Acute Kidney Injury-REVERSE-AKI randomized controlled pilot trial. Acta Anaesthesiol Scand. 2020 Jul;64(6):831-838. doi: 10.1111/aas.13557. Epub 2020 Feb 26.

  PMID: 32022904 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: August 16, 2017
• Study Start: November 8, 2017
• Primary Completion: January 31, 2020
• Study Completion: April 30, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

GB (2); CH (1); BE (1); AU (2); FI (1)