Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID04180397

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

Led by Morten H. Bestle · Updated on 2026-06-03

1000

Participants Needed

29

Research Sites

50 weeks

Total Duration

On this page

Sponsors

M

Morten H. Bestle

Lead Sponsor

U

University of Copenhagen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the benefits and risks of using furosemide, a diuretic, compared to a placebo in critically ill adult patients who experience fluid overload in the intensive care unit (ICU). Fluid overload, a common complication in ICU patients, can worsen outcomes especially in those with acute kidney injury. The study aims to determine if reducing excess fluid with furosemide improves patient health or if fluid overload is simply a marker of severe illness. Participants are randomly assigned to receive either furosemide or a placebo (isotonic saline) through intravenous infusion. The furosemide group receives a bolus dose followed by an infusion adjusted to target a negative fluid balance of 1 ml per kg per hour, with fluid balance monitored three times daily. The placebo group receives saline dosed and adjusted by the same protocol. Treatment continues until the excess fluid is removed and fluid balance is neutral. During the study, participants will be closely monitored for fluid balance and clinical stability. Researchers will assess outcomes including days alive and out of hospital within 90 days, mortality rates up to one year, serious adverse events, quality of life, and cognitive function. The study involves a randomized, blinded design to compare the effects of furosemide versus placebo over a one-year follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute admission to the intensive care unit.
  • Age 18 years or older.
  • Fluid overload of 5% or more of ideal body weight including fluids given before ICU admission.
  • Clinically stable with mean arterial pressure above 50 mmHg and limited noradrenaline infusion (maximum 20 microgram/kg/min) and lactate under 4.0 mmol/L.
Not Eligible

You will not qualify if you...

  • Known allergy to furosemide or sulphonamides.
  • Advanced chronic kidney disease before hospitalization (eGFR under 30 mL/min/1.73 m²) or chronic renal replacement therapy.
  • Currently undergoing renal replacement therapy.
  • Anuria lasting more than 6 hours.
  • Rhabdomyolysis requiring forced diuresis.
  • Ongoing life-threatening bleeding requiring special fluid or blood product management.
  • Acute burn injury covering more than 10% of body surface area.
  • Severe sodium imbalance (p-Na below 120 or above 155 mmol/L).
  • Severe liver failure as determined by clinical team.
  • Patients under forced treatment.
  • Fertile women under 50 years with positive pregnancy test.
  • Consent not obtainable according to trial site model.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Until fluid balance is assessed neutral

Participants receive goal directed fluid removal with either furosemide or placebo infusion to achieve a negative fluid balance, monitored multiple times daily.

Daily assessments with fluid balance calculated three times per day

Follow-up

Duration - Up to 1 year after randomization

Participants are followed up for survival, adverse events, and quality of life outcomes after treatment ends.

Assessments at 90 days and 1 year after randomization

Trial Site Locations

Total: 29 locations

1

Department of Intensive Care, Liverpool Hospital

Sydney, Australia

Actively Recruiting

2

Department of Intensive Care, Royal North Shore Hospital

Sydney, Australia

Actively Recruiting

3

Department of Intensive Care, University Hospital of Ostrava

Ostrava, Czechia

Not Yet Recruiting

4

Department of Intensive Care, University Hospital of Pilsen

Pilsen, Czechia

Actively Recruiting

5

Department of Intensive Care, IKEM

Prague, Czechia

Actively Recruiting

6

Department of Intensive Care, Sygehus Sønderjylland Aabenraa

Aabenraa, Denmark

Terminated

7

Departmen of Intensive Care

Aalborg, Denmark, 9000

Actively Recruiting

8

Department of Intensive Care, Aarhus University Hospital

Aarhus, Denmark

Terminated

9

Department of Intensive Care, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

10

Departement of Intensive Care, Gentofte Hospital

Gentofte Municipality, Denmark

Terminated

11

Department of Intensive Care, Herlev Hospital

Herlev, Denmark, 2730

Actively Recruiting

12

Department of Intensive Care, Regionshospital Gødstrup

Herning, Denmark, 7400

Actively Recruiting

13

Department of Intensive Care, Nordsjællands hospital

Hillerød, Denmark

Actively Recruiting

14

Department of Intensive Care, Regionshospital Nordjylland Hjørring

Hjørring, Denmark

Actively Recruiting

15

Department of Intensive Care

Kolding, Denmark, 6000

Actively Recruiting

16

Department of Intensive Care, Zealand University hospital

Køge, Denmark, 4600

Actively Recruiting

17

Department of Intensive Care

Odense, Denmark, 5000

Actively Recruiting

18

Department of Intensive Care, Regionshospitalet Randers

Randers, Denmark, 8930

Actively Recruiting

19

Department of Intensive Care, University Hospital Zealand, Roskilde

Roskilde, Denmark

Actively Recruiting

20

Department of Intensive Care

Vejle, Denmark, 7100

Withdrawn

21

Regionshospitalet Viborg

Viborg, Denmark, 8800

Actively Recruiting

22

Department of Intensive Care, Tampere University Hospital

Tampere, Finland, 33520

Terminated

23

Department of Intensive Care

Turku, Finland

Terminated

24

Department of Intensive Care, Landspitali National University Hospital of Iceland

Reykjavik, Iceland

Terminated

25

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

Actively Recruiting

26

Department of Critical Care, University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

27

Department of Intensive Care, Ålesund Sjukehus

Ålesund, Norway

Terminated

28

Department of Intensive Care, Stavanger University Hospital

Stavanger, Norway, 4068

Terminated

29

Department of Intensive Care, Inselspital

Bern, Switzerland

Actively Recruiting

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Research Team

S

Sine Wichmann, MD

M

Morten Bestle, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Furosemide versus placebo for fluid overload in intensive care patients-The randomised GODIF trial second version: Statistical analysis plan.

Sine Wichmann, Theis Lange, Anders Perner...

https://pubmed.ncbi.nlm.nih.gov/37691474

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).

Sine Wichmann, Theis S Itenov, Rasmus E Berthelsen...

https://pubmed.ncbi.nlm.nih.gov/35898170