REVERSE-AKI Randomized Controlled Pilot Trial (REVERSE-AKI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03251131|
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : December 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury Critical Illness||Other: Restrictive fluid management||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial|
|Actual Study Start Date :||November 8, 2017|
|Actual Primary Completion Date :||January 31, 2020|
|Actual Study Completion Date :||April 30, 2020|
Experimental: Restrictive fluid management
Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.
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.
No Intervention: Standard therapy
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.
- Cumulative fluid balance [ Time Frame: 72 hours ]
- Duration of acute kidney injury [ Time Frame: ICU discharge/14 days ]Defined according to Kidney Disease: Improving Global Outcomes criteria
- Number of patients requiring renal replacement therapy [ Time Frame: 14 days ]
- Cumulative fluid balance [ Time Frame: 24 hours ]
- Cumulative fluid balance [ Time Frame: ICU discharge/ 7 days ]
- Cumulative dose of diuretics [ Time Frame: ICU discharge/ 7 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
- Mechanical ventilation free days alive [ Time Frame: 14 days ]
- Vasopressor free days and alive [ Time Frame: 14 days ]
- Renal replacement therapy free days and alive [ Time Frame: 90 days ]
- Dialysis dependence [ Time Frame: 90 days ]
- All-cause mortality [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251131
|Melbourne, Victoria, Australia, 3048|
|Ghent University Hospital|
|Helsinki University Hospital|
|Lausanne University Hospital|
|Guy's and St Thomas Hospital|
|London, United Kingdom|
|Royal London Hospital, Barts Health NHS Trust|
|London, United Kingdom|
|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|