drugset / Trial / NCT02458157
Forced Fluid Removal in High Risk Acute Kidney Injury
Phase 4
Terminated
21 enrolled
Nordsjaellands Hospital
Aalborg University Hospital · collabRigshospitalet, Denmark · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The objective of this pilot trial is to assess the feasibility of forced fluid removal in patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid overload. The intervention will use furosemide infusion and/or continuous renal replacement therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention will be compared to standard of care as reflected in the kidney disease improving global outcome (KDIGO) guidelines.
Timeline
- Start
- 2015-10
- Primary completion
- 2017-06-08
- Completion
- 2017-06-08
Outcome
Met primary endpoint
Stopped (Enrollment): “Very low recruitment rates”
paper marked reduction in cumulative fluid balance 5 days after randomisation (mean difference -5814 mL, 95% CI -2063 to -9565, P = .003) PMID 29664109 ↗
Publications
- Berthelsen RE, Perner A, Jensen AK, Rasmussen BS, Jensen JU, Wiis J, Behzadi MT, Bestle MH. Forced fluid removal in intensive care patients with acute kidney injury: The randomised FFAKI feasibility trial. Acta Anaesthesiol Scand. 2018 Aug;62(7):936-944. doi: 10.1111/aas.13124. Epub 2018 Apr 17.
- Berthelsen RE, Itenov T, Perner A, Jensen JU, Ibsen M, Jensen AEK, Bestle M. Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial. Trials. 2017 Apr 24;18(1):189. doi: 10.1186/s13063-017-1935-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Furosemide | Other / unclassified | 40 mg | Intravenous |