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Trial record 1 of 1 for:    GODIF | Denmark
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Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit. (GODIF)

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ClinicalTrials.gov Identifier: NCT04180397
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : August 19, 2020
Sponsor:
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

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

Detailed Description:
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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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 in Intensive Care Patients With Fluid Overload - A Randomized, Blinded, Placebo-controlled Trial (GODIF).
Estimated Study Start Date : August 17, 2020
Estimated Primary Completion Date : August 17, 2022
Estimated Study Completion Date : November 17, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: Furosemide
40 mg (4 ml) of furosemide iv. 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 +/- 750 ml.
Drug: Furosemide
Furosemide 10 mg/ml for injection/infusion
Other Name: Furix

Placebo Comparator: Placebo
Isotonic saline dosed the same way and by the same algorithm as for furosemide. Start bolus of 4 ml. Infusion is started at 2 ml/hour and adjusted according to effect and fluid balance. Infusion rate: 0 - 4 ml/hour. Stopped when the fluid balance is +/- 750 ml.
Drug: Isotonic saline
Isotonic saline used as placebo (injection/infusion)




Primary Outcome Measures :
  1. Days alive and out of hospital [ Time Frame: 90 days after randomization ]
    Days alive and out of hospital


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 90 days after randomization ]
    All cause mortality

  2. 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)

  3. Mortality 1 year [ Time Frame: one year after randomization ]
    All cause mortality

  4. Serious adverse events and reactions [ Time Frame: 90 days ]
    Number of participants with one or more serious adverse events and serious adverse reactions

  5. 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.

  6. 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.



Information from the National Library of Medicine

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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 defined as a positive cumulative fluid balance (according to the daily fluid charts) corresponding ≥ 5% of ideal body weight (calculated as: 22 x (height in meters)^2). 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 defined as 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.
  • 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
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Contact: Sine Wichmann, MD +45 26142620 sine.wichmann@regionh.dk
Contact: Morten Bestle, MD +45 41951195 morten.bestle@regionh.dk

Locations
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Denmark
Departmen of Intensive Care Not yet recruiting
Aalborg, Denmark, 9000
Department of Intensive Care, Rigshospitalet Not yet recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Anders Perner, MD         
Department of Intensive Care Not yet recruiting
Hellerup, Denmark, 2900
Nordsjællands hospital Recruiting
Hillerød, Denmark, 3400
Principal Investigator: Morten Bestle, MD         
Department of Intensive Care Not yet recruiting
Kolding, Denmark, 6000
Department of Intensive Care Not yet recruiting
Køge, Denmark, 4600
Department of Intensive Care Not yet recruiting
Vejle, Denmark, 7100
Contact: Department of I Care         
Department of Intensive Care Not yet recruiting
Viborg, Denmark, 8800
Contact: Department of I Care         
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
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Study Chair: Morten Bestle, MD Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital
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Responsible Party: Morten H. Bestle, Senior staff specialist and Associate Professor, Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT04180397    
Other Study ID Numbers: GODIF
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Fluid overload
Fluid removal
Oedema
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