Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2017-11-08
2020-04-30
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Restrictive fluid management
Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.
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.
Standard therapy
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Austin Hospital, Melbourne Australia
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
University Hospital, Ghent
OTHER
Medical University Innsbruck
OTHER
University of Lausanne Hospitals
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Suvi Vaara
MD, PhD
Principal Investigators
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Suvi Vaara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
Marlies Ostermann, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London
Locations
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Austin Hospital
Melbourne, Victoria, Australia
Canberra Hospital
Canberra, , Australia
Ghent University Hospital
Ghent, , Belgium
Helsinki University Hospital
Helsinki, , Finland
Lausanne University Hospital
Lausanne, , Switzerland
Guy's and St Thomas Hospital
London, , United Kingdom
Royal London Hospital, Barts Health NHS Trust
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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HUS/1782/2017
Identifier Type: -
Identifier Source: org_study_id