drugset / Trial / NCT04180397
Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
Phase 4
Recruiting
1000 enrolled
Morten H. Bestle
Centre for Research in Intensive Care (CRIC) · collabCopenhagen Trial Unit, Center for Clinical Intervention Research · collabUniversity of Copenhagen · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.
Timeline
- Start
- 2020-08-17
- Primary completion
- 2027-04-30
- Completion
- 2028-04-15
Publications
- Wichmann S, Lange T, Perner A, Gluud C, Itenov TS, Berthelsen RE, Nebrich L, Wiis J, Brochner AC, Nielsen LG, Behzadi MT, Damgaard K, Andreasen AS, Strand K, Jarvisalo M, Strom T, Eschen CT, Vang ML, Hildebrandt T, Andersen FH, Sigurdsson MI, Thomar KM, Thygesen SK, Troelsen TT, Uusalo P, Jalkanen V, Illum D, Solling C, Keus F, Pfortmueller CA, Wahlin RR, Ostermann M, Aneman A, Bestle MH. Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version: Statistical analysis plan. Acta Anaesthesiol Scand. 2024 Jan;68(1):130-136. doi: 10.1111/aas.14320. Epub 2023 Sep 11.
- Wichmann S, Itenov TS, Berthelsen RE, Lange T, Perner A, Gluud C, Lawson-Smith P, Nebrich L, Wiis J, Brochner AC, Hildebrandt T, Behzadi MT, Strand K, Andersen FH, Strom T, Jarvisalo M, Damgaard KAJ, Vang ML, Wahlin RR, Sigurdsson MI, Thormar KM, Ostermann M, Keus F, Bestle MH. Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload: A trial protocol for a randomised, blinded trial (GODIF trial). Acta Anaesthesiol Scand. 2022 Oct;66(9):1138-1145. doi: 10.1111/aas.14121. Epub 2022 Aug 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Furosemide | Other / unclassified | 5 mg | Intravenous |
| Comparator | Furosemide | Other / unclassified | 20 mg | Intravenous |
| Comparator | Furosemide | Other / unclassified | 40 mg | Intravenous |
Indications
No indication recorded.