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

June 2, 2026 updated by: Morten H. Bestle

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
      • Sydney, Australia
        • Recruiting
        • Department of Intensive Care, Liverpool Hospital
        • Principal Investigator:
          • Anders Aneman, MD, PhD
      • Sydney, Australia
        • Recruiting
        • Department of Intensive Care, Royal North Shore Hospital
        • Principal Investigator:
          • Anthony Delaney, Ass. professor
  • Czechia
      • Ostrava, Czechia
        • Not yet recruiting
        • Department of Intensive Care, University Hospital of Ostrava
        • Principal Investigator:
          • Jan Máca, MD, PhD
      • Pilsen, Czechia
        • Recruiting
        • Department of Intensive Care, University Hospital of Pilsen
        • Principal Investigator:
          • Marek Nalos, MD, PhD
      • Prague, Czechia
        • Recruiting
        • Department of Intensive Care, IKEM
        • Principal Investigator:
          • Petr Piza, MD
  • Denmark
      • Aabenraa, Denmark
        • Terminated
        • Department of Intensive Care, Sygehus Sønderjylland Aabenraa
      • Aalborg, Denmark, 9000
        • Recruiting
        • Departmen of Intensive Care
        • Principal Investigator:
          • Meike T Behazadi, MD
      • Aarhus, Denmark
        • Terminated
        • Department of Intensive Care, Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Intensive Care, Rigshospitalet
        • Principal Investigator:
          • Anders Bastiansen, MD
      • Gentofte Municipality, Denmark
        • Terminated
        • Departement of Intensive Care, Gentofte Hospital
      • Herlev, Denmark, 2730
        • Recruiting
        • Department of Intensive Care, Herlev Hospital
        • Principal Investigator:
          • Anne Sofie Andreasen, MD, PhD
      • Herning, Denmark, 7400
        • Recruiting
        • Department of Intensive Care, Regionshospital Gødstrup
        • Principal Investigator:
          • Thomas Troelsen, MD
      • Hillerød, Denmark
        • Recruiting
        • Department of Intensive Care, Nordsjællands hospital
        • Principal Investigator:
          • Sine Wichmann, MD, PhD, Ass. professor
      • Hjørring, Denmark
        • Recruiting
        • Department of Intensive Care, Regionshospital Nordjylland Hjørring
        • Principal Investigator:
          • Kjeld Damgaard, MD, PhD
      • Kolding, Denmark, 6000
        • Recruiting
        • Department of Intensive Care
        • Principal Investigator:
          • Anne C Brøchner, MD, PhD
      • Køge, Denmark, 4600
        • Recruiting
        • Department of Intensive Care, Zealand University hospital
        • Principal Investigator:
          • Lars Nebrich, MD
      • Odense, Denmark, 5000
        • Recruiting
        • Department of Intensive Care
        • Principal Investigator:
          • Louise G Nielsen, MD
      • Randers, Denmark, 8930
        • Recruiting
        • Department of Intensive Care, Regionshospitalet Randers
        • Principal Investigator:
          • Marianne Vang, MD
      • Roskilde, Denmark
        • Recruiting
        • Department of Intensive Care, University Hospital Zealand, Roskilde
        • Principal Investigator:
          • Thomas Hildebrandt, MD
      • Vejle, Denmark, 7100
        • Withdrawn
        • Department of Intensive Care
      • Viborg, Denmark, 8800
        • Recruiting
        • Regionshospitalet Viborg
        • Principal Investigator:
          • Christoffer Grant Sølling, MD, PhD
  • Finland
      • Tampere, Finland, 33520
        • Terminated
        • Department of Intensive Care, Tampere University Hospital
      • Turku, Finland
        • Terminated
        • Department of Intensive Care
  • Iceland
      • Reykjavik, Iceland
        • Terminated
        • Department of Intensive Care, Landspitali National University Hospital of Iceland
  • Lithuania
      • Vilnius, Lithuania
        • Recruiting
        • Vilnius University Hospital Santaros Clinics
        • Principal Investigator:
          • Ieva Jovaišienė, Professor
  • Netherlands
      • Groningen, Netherlands
        • Recruiting
        • Department of Critical Care, University Medical Center Groningen
        • Principal Investigator:
          • Eric Keus, MD
  • Norway
      • Stavanger, Norway, 4068
        • Terminated
        • Department of Intensive Care, Stavanger University Hospital
      • Ålesund, Norway
        • Terminated
        • Department of Intensive Care, Ålesund Sjukehus
  • Switzerland
      • Bern, Switzerland
        • Recruiting
        • Department of Intensive Care, Inselspital
        • Contact:
          • Carmen Pfortmueller, MD, PhD
        • Principal Investigator:
          • Jan Waskowski, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Furosemide
Furosemide 10 mg/ml for injection/infusion
Other Names:
  • Furix
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.
Drug: Isotonic saline
Isotonic saline used as placebo (injection/infusion)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days alive and out of hospital
Time Frame: 90 days after randomization
Days alive and out of hospital
90 days after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 90 days after randomization
All cause mortality
90 days after randomization
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)
90 days after randomization
Mortality 1 year
Time Frame: one year after randomization
All cause mortality
one year after randomization
Serious adverse events and reactions
Time Frame: 90 days
Number of participants with one or more serious adverse events and serious adverse reactions
90 days
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.
1 year after randomization
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.
1 year after randomization
Health related quality of life
Time Frame: 1 year after randomization
Subjective assessment (unacceptable, neutral, acceptable)
1 year after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Morten H. Bestle

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Centre for Research in Intensive Care (CRIC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Morten Bestle, MD, Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GODIF
  • 2024-512186-14-00 (Ctis)
  • 2019-004292-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

will be made available on reasonable request after the primary results are published

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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