Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit. (GODIF)
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| ClinicalTrials.gov Identifier: NCT04180397 |
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Recruitment Status :
Recruiting
First Posted : November 27, 2019
Last Update Posted : December 27, 2022
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Sponsor:
Morten H. Bestle
Collaborators:
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Centre for Research in Intensive Care (CRIC)
Information provided by (Responsible Party):
Morten H. Bestle, Nordsjaellands Hospital
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fluid Overload | Drug: Furosemide Drug: Isotonic saline | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF). |
| Actual Study Start Date : | August 17, 2020 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | June 17, 2025 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Furosemide
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Furosemide
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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Drug: Furosemide
Furosemide 10 mg/ml for injection/infusion
Other Name: Furix |
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Placebo Comparator: Placebo
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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Drug: Isotonic saline
Isotonic saline used as placebo (injection/infusion) |
Primary Outcome Measures :
- Days alive and out of hospital [ Time Frame: 90 days after randomization ]Days alive and out of hospital
Secondary Outcome Measures :
- All cause mortality [ Time Frame: 90 days after randomization ]All cause mortality
- Mortality and life support [ Time Frame: 90 days after randomization ]Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy)
- Mortality 1 year [ Time Frame: one year after randomization ]All cause mortality
- Serious adverse events and reactions [ Time Frame: 90 days ]Number of participants with one or more serious adverse events and serious adverse reactions
- Health related quality of life [ Time Frame: 1 year after randomization ]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.
- Cognitive function [ Time Frame: 1 year after randomization ]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.
- Health related quality of life [ Time Frame: 1 year after randomization ]Subjective assessment (unacceptable, neutral, acceptable)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: ALL below must be met.
- Acute admission to the intensive care unit.
- Age ≥ 18 years of age
- Fluid overload ≥ 5% of ideal body weight. If possible, all fluids administered before admission to the intensive care unit are to be included in the calculation of cumulative fluid balance.
- Clinical stable (minimum criteria: MAP > 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/L)
Exclusion Criteria:
- Known allergy to furosemide or sulphonamides.
- Known pre-hospitalization advanced chronic kidney disease (eGFR < 30 mL/minute/1.73 m^2 or chronic RRT).
- Ongoing renal replacement therapy.
- Anuria > 6 hours.
- Rhabdomyolysis with indication for forced diuresis
- Ongoing life-threatening bleeding as these patients need specific fluid/blood product strategies.
- Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy.
- Severe dysnatremia (p-Na < 120 or > 155 mmol/L) as these patients need a specific fluid strategy.
- Severe hepatic failure as per the clinical team.
- Patients undergoing forced treatment.
- Fertile women (women < 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG.
- Consent not obtainable as per the model approved for the specific trial site.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180397
Contacts
| Contact: Sine Wichmann, MD | +45 26142620 | sine.wichmann@regionh.dk | |
| Contact: Morten Bestle, MD | +45 41951195 | morten.bestle@regionh.dk |
Locations
Show 18 study locations
Sponsors and Collaborators
Morten H. Bestle
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Centre for Research in Intensive Care (CRIC)
Investigators
| Study Chair: | Morten Bestle, MD | Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Morten H. Bestle, Senior staff specialist and Professor, Nordsjaellands Hospital |
| ClinicalTrials.gov Identifier: | NCT04180397 |
| Other Study ID Numbers: |
GODIF |
| First Posted: | November 27, 2019 Key Record Dates |
| Last Update Posted: | December 27, 2022 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | will be made available on reasonable request after the primary results are published |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Morten H. Bestle, Nordsjaellands Hospital:
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Fluid overload Fluid removal Deresusciation Diuretics Fluid accumulation |
Additional relevant MeSH terms:
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Furosemide Diuretics Natriuretic Agents Physiological Effects of Drugs |
Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |