Back to resultsREVERSE-AKI Randomized Controlled Pilot Trial (REVERSE-AKI)
Primary Purpose
Acute Kidney Injury, Critical Illness
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Restrictive fluid management
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- 18-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
Exclusion Criteria:
- 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
Sites / Locations
- Austin Hospital
- Canberra Hospital
- Ghent University Hospital
- Helsinki University Hospital
- Lausanne University Hospital
- Guy's and St Thomas Hospital
- Royal London Hospital, Barts Health NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Restrictive fluid management
Standard therapy
Arm Description
Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.
Outcomes
Primary Outcome Measures
Cumulative fluid balance
Secondary Outcome Measures
Duration of acute kidney injury
Defined according to Kidney Disease: Improving Global Outcomes criteria
Number of patients requiring renal replacement therapy
Cumulative fluid balance
Cumulative fluid balance
Cumulative dose of diuretics
Full Information
NCT ID
NCT03251131
First Posted
August 12, 2017
Last Updated
December 10, 2020
Sponsor
Helsinki University Central Hospital
Collaborators
Austin Hospital, Melbourne Australia, Guy's and St Thomas' NHS Foundation Trust, University Hospital, Ghent, Medical University Innsbruck, Lausanne University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03251131
Brief Title
REVERSE-AKI Randomized Controlled Pilot Trial
Acronym
REVERSE-AKI
Official Title
REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Austin Hospital, Melbourne Australia, Guy's and St Thomas' NHS Foundation Trust, University Hospital, Ghent, Medical University Innsbruck, Lausanne University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Critical Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Restrictive fluid management
Arm Type
Experimental
Arm Description
Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.
Intervention Type
Other
Intervention Name(s)
Restrictive fluid management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative fluid balance
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Duration of acute kidney injury
Description
Defined according to Kidney Disease: Improving Global Outcomes criteria
Time Frame
ICU discharge/14 days
Title
Number of patients requiring renal replacement therapy
Time Frame
14 days
Title
Cumulative fluid balance
Time Frame
24 hours
Title
Cumulative fluid balance
Time Frame
ICU discharge/ 7 days
Title
Cumulative dose of diuretics
Time Frame
ICU discharge/ 7 days
Other Pre-specified Outcome Measures:
Title
Number of patients with serious adverse events and reactions
Description
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
Time Frame
7 days
Title
Mechanical ventilation free days alive
Time Frame
14 days
Title
Vasopressor free days and alive
Time Frame
14 days
Title
Renal replacement therapy free days and alive
Time Frame
90 days
Title
Dialysis dependence
Time Frame
90 days
Title
All-cause mortality
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suvi Vaara, MD, PhD
Organizational Affiliation
Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marlies Ostermann, MD, PhD
Organizational Affiliation
Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3048
Country
Australia
Facility Name
Canberra Hospital
City
Canberra
Country
Australia
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Lausanne University Hospital
City
Lausanne
Country
Switzerland
Facility Name
Guy's and St Thomas Hospital
City
London
Country
United Kingdom
Facility Name
Royal London Hospital, Barts Health NHS Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32022904
Citation
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.
Results Reference
derived
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REVERSE-AKI Randomized Controlled Pilot Trial
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