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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04180397




Registration number
NCT04180397
Ethics application status
Date submitted
25/11/2019
Date registered
27/11/2019
Date last updated
6/02/2025

Titles & IDs
Public title
Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.
Scientific title
Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).
Secondary ID [1] 0 0
GODIF
Universal Trial Number (UTN)
Trial acronym
GODIF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fluid Overload 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Furosemide
Treatment: Drugs - Isotonic saline

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.

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.


Treatment: Drugs: Furosemide
Furosemide 10 mg/ml for injection/infusion

Treatment: Drugs: Isotonic saline
Isotonic saline used as placebo (injection/infusion)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days alive and out of hospital
Timepoint [1] 0 0
90 days after randomization
Secondary outcome [1] 0 0
All cause mortality
Timepoint [1] 0 0
90 days after randomization
Secondary outcome [2] 0 0
Mortality and life support
Timepoint [2] 0 0
90 days after randomization
Secondary outcome [3] 0 0
Mortality 1 year
Timepoint [3] 0 0
one year after randomization
Secondary outcome [4] 0 0
Serious adverse events and reactions
Timepoint [4] 0 0
90 days
Secondary outcome [5] 0 0
Health related quality of life
Timepoint [5] 0 0
1 year after randomization
Secondary outcome [6] 0 0
Cognitive function
Timepoint [6] 0 0
1 year after randomization
Secondary outcome [7] 0 0
Health related quality of life
Timepoint [7] 0 0
1 year after randomization

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/03/2028
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Intensive Care, Liverpool Hospital - Sidney
Recruitment postcode(s) [1] 0 0
- Sidney
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aabenraa
Country [2] 0 0
Denmark
State/province [2] 0 0
Aalborg
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus
Country [4] 0 0
Denmark
State/province [4] 0 0
Copenhagen
Country [5] 0 0
Denmark
State/province [5] 0 0
Gentofte
Country [6] 0 0
Denmark
State/province [6] 0 0
Herlev
Country [7] 0 0
Denmark
State/province [7] 0 0
Herning
Country [8] 0 0
Denmark
State/province [8] 0 0
Hillerød
Country [9] 0 0
Denmark
State/province [9] 0 0
Hjørring
Country [10] 0 0
Denmark
State/province [10] 0 0
Kolding
Country [11] 0 0
Denmark
State/province [11] 0 0
Køge
Country [12] 0 0
Denmark
State/province [12] 0 0
Odense
Country [13] 0 0
Denmark
State/province [13] 0 0
Randers
Country [14] 0 0
Denmark
State/province [14] 0 0
Roskilde
Country [15] 0 0
Denmark
State/province [15] 0 0
Vejle
Country [16] 0 0
Denmark
State/province [16] 0 0
Viborg
Country [17] 0 0
Finland
State/province [17] 0 0
Tampere
Country [18] 0 0
Finland
State/province [18] 0 0
Turku
Country [19] 0 0
Iceland
State/province [19] 0 0
Reykjavík
Country [20] 0 0
Netherlands
State/province [20] 0 0
Groningen
Country [21] 0 0
Norway
State/province [21] 0 0
Stavanger
Country [22] 0 0
Norway
State/province [22] 0 0
Ålesund
Country [23] 0 0
Switzerland
State/province [23] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Other
Name
Morten H. Bestle
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Copenhagen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Copenhagen Trial Unit, Center for Clinical Intervention Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Centre for Research in Intensive Care (CRIC)
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04180397
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Morten Bestle, MD
Address 0 0
Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sine Wichmann, MD
Address 0 0
Country 0 0
Phone 0 0
+45 26142620
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04180397