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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03251131




Registration number
NCT03251131
Ethics application status
Date submitted
12/08/2017
Date registered
16/08/2017
Date last updated
14/12/2020

Titles & IDs
Public title
REVERSE-AKI Randomized Controlled Pilot Trial
Scientific title
REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial
Secondary ID [1] 0 0
HUS/1782/2017
Universal Trial Number (UTN)
Trial acronym
REVERSE-AKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 0 0
Critical Illness 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Restrictive fluid management

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

No intervention: Standard therapy - Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative fluid balance
Timepoint [1] 0 0
72 hours
Secondary outcome [1] 0 0
Duration of acute kidney injury
Timepoint [1] 0 0
ICU discharge/14 days
Secondary outcome [2] 0 0
Number of patients requiring renal replacement therapy
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Cumulative fluid balance
Timepoint [3] 0 0
24 hours
Secondary outcome [4] 0 0
Cumulative fluid balance
Timepoint [4] 0 0
ICU discharge/ 7 days
Secondary outcome [5] 0 0
Cumulative dose of diuretics
Timepoint [5] 0 0
ICU discharge/ 7 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2020
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment hospital [2] 0 0
Canberra Hospital - Canberra
Recruitment postcode(s) [1] 0 0
3048 - Melbourne
Recruitment postcode(s) [2] 0 0
- Canberra
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Ghent
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
Switzerland
State/province [3] 0 0
Lausanne
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Helsinki University Central Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Hospital, Melbourne Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Guy's and St Thomas' NHS Foundation Trust
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University Hospital, Ghent
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Medical University Innsbruck
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Lausanne University Hospital
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03251131
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Suvi Vaara, MD, PhD
Address 0 0
Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03251131