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Fluid OverloadPhase 4GODIFNCT04180397

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

A Phase 4 study testing Furosemide and Isotonic saline in people with Fluid Overload, run by Morten H. Bestle at 29 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fluid Overload
What is being tested?
Furosemide and Isotonic saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
29 sitesin 9 countries
Study dates
17 Aug 2020to 15 Apr 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

29 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Sine Wichmann, MD contact

+45 26142620

sine.wichmann@regionh.dk

Morten Bestle, MD contact

+45 41951195

morten.bestle@regionh.dk

29 sites in 9 countries

Denmark16 sites, 12 recruiting

  • Department of Intensive Care, Sygehus Sønderjylland Aabenraa

    Aabenraa

    Terminated

  • Departmen of Intensive Care

    Aalborg, 9000

    Meike T Behazadi, MD

    Recruiting

  • Department of Intensive Care, Aarhus University Hospital

    Aarhus

    Terminated

  • Department of Intensive Care, Rigshospitalet

    Copenhagen, 2100

    Anders Bastiansen, MD

    Recruiting

  • Departement of Intensive Care, Gentofte Hospital

    Gentofte Municipality

    Terminated

  • Department of Intensive Care, Herlev Hospital

    Herlev, 2730

    Anne Sofie Andreasen, MD, PhD

    Recruiting

  • Department of Intensive Care, Regionshospital Gødstrup

    Herning, 7400

    Thomas Troelsen, MD

    Recruiting

  • Department of Intensive Care, Nordsjællands hospital

    Hillerød

    Sine Wichmann, MD, PhD, Ass. professor

    Recruiting

  • Department of Intensive Care, Regionshospital Nordjylland Hjørring

    Hjørring

    Kjeld Damgaard, MD, PhD

    Recruiting

  • Department of Intensive Care, Zealand University hospital

    Køge, 4600

    Lars Nebrich, MD

    Recruiting

  • Department of Intensive Care

    Kolding, 6000

    Anne C Brøchner, MD, PhD

    Recruiting

  • Department of Intensive Care

    Odense, 5000

    Louise G Nielsen, MD

    Recruiting

  • Department of Intensive Care, Regionshospitalet Randers

    Randers, 8930

    Marianne Vang, MD

    Recruiting

  • Department of Intensive Care, University Hospital Zealand, Roskilde

    Roskilde

    Thomas Hildebrandt, MD

    Recruiting

  • Department of Intensive Care

    Vejle, 7100

    Withdrawn

  • Regionshospitalet Viborg

    Viborg, 8800

    Christoffer Grant Sølling, MD, PhD

    Recruiting

Other trials in Denmark

Czechia3 sites, 3 recruiting

  • Department of Intensive Care, University Hospital of Ostrava

    Ostrava

    Jan Máca, MD, PhD

    Not yet recruiting

  • Department of Intensive Care, University Hospital of Pilsen

    Pilsen

    Marek Nalos, MD, PhD

    Recruiting

  • Department of Intensive Care, IKEM

    Prague

    Petr Piza, MD

    Recruiting

Other trials in Czechia

Australia2 sites, 2 recruiting

  • Department of Intensive Care, Liverpool Hospital

    Sydney

    Anders Aneman, MD, PhD

    Recruiting

  • Department of Intensive Care, Royal North Shore Hospital

    Sydney

    Anthony Delaney, Ass. professor

    Recruiting

Other trials in Australia

Finland2 sites

  • Department of Intensive Care, Tampere University Hospital

    Tampere, 33520

    Terminated

  • Department of Intensive Care

    Turku

    Terminated

Other trials in Finland

Norway2 sites

  • Department of Intensive Care, Ålesund Sjukehus

    Ålesund

    Terminated

  • Department of Intensive Care, Stavanger University Hospital

    Stavanger, 4068

    Terminated

Other trials in Norway

Iceland1 site

  • Department of Intensive Care, Landspitali National University Hospital of Iceland

    Reykjavik

    Terminated

Other trials in Iceland

Lithuania1 site, 1 recruiting

  • Vilnius University Hospital Santaros Clinics

    Vilnius

    Ieva Jovaišienė, Professor

    Recruiting

Other trials in Lithuania

Netherlands1 site, 1 recruiting

  • Department of Critical Care, University Medical Center Groningen

    Groningen

    Eric Keus, MD

    Recruiting

Other trials in Netherlands

Switzerland1 site, 1 recruiting

  • Department of Intensive Care, Inselspital

    Bern

    Carmen Pfortmueller, MD, PhD

    Jan Waskowski, MD, PhD

    Recruiting

Other trials in Switzerland

About this study

Official title: Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).

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.

Read the 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.

Conditions
Fluid Overload
Being tested
Furosemide, Isotonic saline
Keywords
Fluid overload, Fluid removal, Deresusciation, Diuretics, Fluid accumulation
Medical subject headings
Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FurosemideDrug

    Also called Furix

    Furosemide 10 mg/ml for injection/infusion

  • Isotonic salineDrug

    Isotonic saline used as placebo (injection/infusion)

Study groups in NCT04180397
Study groupRoleWhat they receive
FurosemideActive comparatorBolus 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.
Receives: Drug: Furosemide
PlaceboPlacebo comparatorIsotonic 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.
Receives: Drug: Isotonic saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days alive and out of hospital

    Days alive and out of hospital

    Measured: 90 days after randomization

Secondary outcomes (7)

  1. All cause mortality

    All cause mortality

    Measured: 90 days after randomization

  2. Mortality and life support

    Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy)

    Measured: 90 days after randomization

  3. Mortality 1 year

    All cause mortality

    Measured: one year after randomization

  4. Serious adverse events and reactions

    Number of participants with one or more serious adverse events and serious adverse reactions

    Measured: 90 days

  5. 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.

    Measured: 1 year after randomization

  6. 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.

    Measured: 1 year after randomization

  7. Health related quality of life

    Subjective assessment (unacceptable, neutral, acceptable)

    Measured: 1 year after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start17 Aug 2020
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion15 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04180397
Sponsor's protocol ID
GODIF
Other IDs
2024-512186-14-00, 2019-004292-40, 2019
Acronym
GODIF
Status last verified
Jun 2026
First submitted
25 Nov 2019
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: will be made available on reasonable request after the primary results are published

Publications

  • 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.

    PubMed 37691474

  • 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.

    PubMed 35898170

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Furosemide and Isotonic saline in people with Fluid Overload, run by Morten H. Bestle at 29 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Denmark, Czechia, Australia, Finland, Norway and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sine Wichmann, MD (+45 26142620, sine.wichmann@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days alive and out of hospital (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04180397, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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