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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Universal Trial Number (UTN)
Trial acronym
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

Study type
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

Primary outcome [1] 0 0
Cumulative fluid balance
Timepoint [1] 0 0
72 hours
Secondary outcome [1] 0 0
Duration of acute kidney injury - Defined according to Kidney Disease: Improving Global Outcomes criteria
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
Secondary outcome [6] 0 0
All-cause mortality
Timepoint [6] 0 0
90 days

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)

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
Both males and females
Can healthy volunteers participate?
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

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
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
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
State/province [3] 0 0
Country [4] 0 0
United Kingdom
State/province [4] 0 0

Funding & Sponsors
Primary sponsor type
Helsinki University Central Hospital
Other collaborator category [1] 0 0
Name [1] 0 0
Austin Hospital, Melbourne Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
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
Name [3] 0 0
University Hospital, Ghent
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Name [4] 0 0
Medical University Innsbruck
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Name [5] 0 0
Lausanne University Hospital
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Other publications