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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512186-14-00 | EU Trial (CTIS) Number | ||
| 2019-004292-40 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| Centre for Research in Intensive Care (CRIC) | OTHER |
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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.
Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furosemide | Active Comparator | Bolus of 5-40 mg (0.5 - 4 ml) of furosemide iv at physicians discretion followed by infusion of furosemide. Infusion rate: 0-40 mg/hour. Starting rate: 20 mg/hour. The infusion is adjusted according effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral. |
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| Placebo | Placebo Comparator | Isotonic saline dosed the same way and by the same algorithm as for furosemide. Start bolus of 0.5-4 ml at physicians discretion. Infusion rate: 0 - 4 ml/hour. Infusion is started at 2 ml/hour and adjusted according to effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Furosemide 10 mg/ml for injection/infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital | Days alive and out of hospital | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | All cause mortality | 90 days after randomization |
| Mortality and life support | Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy) |
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Inclusion Criteria: ALL below must be met.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sine Wichmann, MD | Contact | +45 26142620 | sine.wichmann@regionh.dk | |
| Morten Bestle, MD | Contact | +45 41951195 | morten.bestle@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Morten Bestle, MD | Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Care, Liverpool Hospital | Recruiting | Sydney | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37691474 | Derived | 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. | |
| 35898170 |
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will be made available on reasonable request after the primary results are published
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| Isotonic saline | Drug | Isotonic saline used as placebo (injection/infusion) |
|
| 90 days after randomization |
| Mortality 1 year | All cause mortality | one year after randomization |
| Serious adverse events and reactions | Number of participants with one or more serious adverse events and serious adverse reactions | 90 days |
| Health related quality of life | Measured using the European quality of Life 5D-5L questionnaire (5D-5L is the full name of the questionnaire). Index value of 1 represents full health and dead = 0. These value sets reflect the preferences of the general population. The European quality of life visual analogue scale is a self-reported assessment of the participant's health status. Scores on 100 = the best health you can imagine and 0 = the worst health you can imagine. | 1 year after randomization |
| Cognitive function | Cognitive function assessed by the Montreal Cognitive Assessment score. Using the mini test for telephone interview. The test and scoring system will soon be published from Montreal Cognitive Assessment. | 1 year after randomization |
| Health related quality of life | Subjective assessment (unacceptable, neutral, acceptable) | 1 year after randomization |
| Department of Intensive Care, Royal North Shore Hospital | Recruiting | Sydney | Australia |
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| Department of Intensive Care, University Hospital of Ostrava | Not yet recruiting | Ostrava | Czechia |
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| Department of Intensive Care, University Hospital of Pilsen | Recruiting | Pilsen | Czechia |
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| Department of Intensive Care, IKEM | Recruiting | Prague | Czechia |
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| Department of Intensive Care, Sygehus Sønderjylland Aabenraa | Terminated | Aabenraa | Denmark |
| Departmen of Intensive Care | Recruiting | Aalborg | 9000 | Denmark |
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| Department of Intensive Care, Aarhus University Hospital | Terminated | Aarhus | Denmark |
| Department of Intensive Care, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| Departement of Intensive Care, Gentofte Hospital | Terminated | Gentofte Municipality | Denmark |
| Department of Intensive Care, Herlev Hospital | Recruiting | Herlev | 2730 | Denmark |
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| Department of Intensive Care, Regionshospital Gødstrup | Recruiting | Herning | 7400 | Denmark |
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| Department of Intensive Care, Nordsjællands hospital | Recruiting | Hillerød | Denmark |
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| Department of Intensive Care, Regionshospital Nordjylland Hjørring | Recruiting | Hjørring | Denmark |
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| Department of Intensive Care | Recruiting | Kolding | 6000 | Denmark |
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| Department of Intensive Care, Zealand University hospital | Recruiting | Køge | 4600 | Denmark |
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| Department of Intensive Care | Recruiting | Odense | 5000 | Denmark |
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| Department of Intensive Care, Regionshospitalet Randers | Recruiting | Randers | 8930 | Denmark |
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| Department of Intensive Care, University Hospital Zealand, Roskilde | Recruiting | Roskilde | Denmark |
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| Department of Intensive Care | Withdrawn | Vejle | 7100 | Denmark |
| Regionshospitalet Viborg | Recruiting | Viborg | 8800 | Denmark |
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| Department of Intensive Care, Tampere University Hospital | Terminated | Tampere | 33520 | Finland |
| Department of Intensive Care | Terminated | Turku | Finland |
| Department of Intensive Care, Landspitali National University Hospital of Iceland | Terminated | Reykjavik | Iceland |
| Vilnius University Hospital Santaros Clinics | Recruiting | Vilnius | Lithuania |
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| Department of Critical Care, University Medical Center Groningen | Recruiting | Groningen | Netherlands |
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| Department of Intensive Care, Ålesund Sjukehus | Terminated | Ålesund | Norway |
| Department of Intensive Care, Stavanger University Hospital | Terminated | Stavanger | 4068 | Norway |
| Department of Intensive Care, Inselspital | Recruiting | Bern | Switzerland |
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| Derived |
| 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. |
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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