- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03251131
REVERSE-AKI Randomized Controlled Pilot Trial (REVERSE-AKI)
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
Conditions
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Canberra, Australia
- Canberra Hospital
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Victoria
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Melbourne, Victoria, Australia, 3048
- Austin Hospital
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Ghent, Belgium
- Ghent University Hospital
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Helsinki, Finland
- Helsinki University Hospital
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Lausanne, Switzerland
- Lausanne University Hospital
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London, United Kingdom
- Royal London Hospital, Barts Health NHS Trust
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London, United Kingdom
- Guy's and St Thomas Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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.
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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.
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No Intervention: Standard therapy
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cumulative fluid balance
Time Frame: 72 hours
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72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of acute kidney injury
Time Frame: ICU discharge/14 days
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Defined according to Kidney Disease: Improving Global Outcomes criteria
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ICU discharge/14 days
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Number of patients requiring renal replacement therapy
Time Frame: 14 days
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14 days
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Cumulative fluid balance
Time Frame: 24 hours
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24 hours
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Cumulative fluid balance
Time Frame: ICU discharge/ 7 days
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ICU discharge/ 7 days
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Cumulative dose of diuretics
Time Frame: ICU discharge/ 7 days
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ICU discharge/ 7 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 90 days
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90 days
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Number of patients with serious adverse events and reactions
Time Frame: 7 days
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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
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Mechanical ventilation free days alive
Time Frame: 14 days
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14 days
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Vasopressor free days and alive
Time Frame: 14 days
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14 days
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Renal replacement therapy free days and alive
Time Frame: 90 days
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90 days
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Dialysis dependence
Time Frame: 90 days
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90 days
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Collaborators and Investigators
Collaborators
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUS/1782/2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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