Status:
COMPLETED
REVERSE-AKI Randomized Controlled Pilot Trial
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Austin Hospital, Melbourne Australia
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Acute Kidney Injury
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 h...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03251131
Start Date
November 8 2017
End Date
April 30 2020
Last Update
December 14 2020
Active Locations (7)
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1
Austin Hospital
Melbourne, Victoria, Australia, 3048
2
Canberra Hospital
Canberra, Australia
3
Ghent University Hospital
Ghent, Belgium
4
Helsinki University Hospital
Helsinki, Finland