Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GODIF | Denmark
Previous Study | Return to List | Next Study

Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit. (GODIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180397
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : June 29, 2021
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

Tracking Information
First Submitted Date  ICMJE November 25, 2019
First Posted Date  ICMJE November 27, 2019
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE August 17, 2020
Estimated Primary Completion Date August 17, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
Days alive and out of hospital [ Time Frame: 90 days after randomization ]
Days alive and out of hospital
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
Mortality [ Time Frame: 90 days after randomization ]
Days alive and out of hospital
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • All cause mortality [ Time Frame: 90 days after randomization ]
    All cause mortality
  • Mortality and life support [ Time Frame: 90 days after ranodimization ]
    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 mortilty
  • Serious adverse events and reactions [ Time Frame: 90 days ]
    Number of participants with one or more serious adverse events and serious adverse reactions
  • Acute kidney injury [ Time Frame: 90 days. ]
    Number of participants developing acute kidney injury and/or recovering from from it during the trial.
  • Health related quality of life (HRQoL) [ Time Frame: 1 year after randomization ]
    HRQoL measured using the EuroQoL (EQ)-5D-5L and EQ-VAS scores
  • Cognitive function [ Time Frame: 1 year after randomization ]
    Cognitive function assessed by the Montreal Cognitive Assessment score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
Official Title  ICMJE Goal Directed Fluid Removal in Intensive Care Patients With Fluid Overload - A Randomized, Blinded, Placebo-controlled Trial (GODIF).
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fluid Overload
Intervention  ICMJE
  • Drug: Furosemide
    Furosemide 10 mg/ml for injection/infusion
    Other Name: Furix
  • Drug: Isotonic saline
    Isotonic saline used as placebo (injection/infusion)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Furosemide
  • 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.
    Intervention: Drug: Isotonic saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2019)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 17, 2024
Estimated Primary Completion Date August 17, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sine Wichmann, MD +45 26142620 sine.wichmann@regionh.dk
Contact: Morten Bestle, MD +45 41951195 morten.bestle@regionh.dk
Listed Location Countries  ICMJE Denmark,   Finland,   Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04180397
Other Study ID Numbers  ICMJE GODIF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Morten H. Bestle, Nordsjaellands Hospital
Study Sponsor  ICMJE Morten H. Bestle
Collaborators  ICMJE
  • University of Copenhagen
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Centre for Research in Intensive Care (CRIC)
Investigators  ICMJE
Study Chair: Morten Bestle, MD Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital
PRS Account Nordsjaellands Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP