Menu
Recruiting NCT04180397

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

Phase IV Interventional Fluid Overload

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Furosemide, Isotonic saline.
Who it may be relevant to
Registry conditions: Fluid Overload. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, Czechia, Denmark, Finland, Iceland +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Furosemide
    Furosemide 10 mg/ml for injection/infusion
  • Drug Isotonic saline
    Isotonic saline used as placebo (injection/infusion)

Primary outcome measures

  • Days alive and out of hospital [Time frame: 90 days after randomization]
Secondary outcome measures (7)
  • All cause mortality [Time frame: 90 days after randomization]
  • Mortality and life support [Time frame: 90 days after randomization]
  • Mortality 1 year [Time frame: one year after randomization]
  • Serious adverse events and reactions [Time frame: 90 days]
  • Health related quality of life [Time frame: 1 year after randomization]
  • Cognitive function [Time frame: 1 year after randomization]
  • Health related quality of life [Time frame: 1 year after randomization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 16 centers
  • Department of Intensive Care, Sygehus Sønderjylland Aabenraa — Aabenraa
  • Departmen of Intensive Care — Aalborg
  • Department of Intensive Care, Aarhus University Hospital — Aarhus
  • Department of Intensive Care, Rigshospitalet — Copenhagen
  • Departement of Intensive Care, Gentofte Hospital — Gentofte Municipality
  • Department of Intensive Care, Herlev Hospital — Herlev
  • Department of Intensive Care, Regionshospital Gødstrup — Herning
  • Department of Intensive Care, Nordsjællands hospital — Hillerød
  • … and 8 more centers
Czechia · 3 centers
  • Department of Intensive Care, University Hospital of Ostrava — Ostrava
  • Department of Intensive Care, University Hospital of Pilsen — Pilsen
  • Department of Intensive Care, IKEM — Prague
Australia · 2 centers
  • Department of Intensive Care, Liverpool Hospital — Sydney
  • Department of Intensive Care, Royal North Shore Hospital — Sydney
Finland · 2 centers
  • Department of Intensive Care, Tampere University Hospital — Tampere
  • Department of Intensive Care — Turku
Norway · 2 centers
  • Department of Intensive Care, Ålesund Sjukehus — Ålesund
  • Department of Intensive Care, Stavanger University Hospital — Stavanger
Iceland · 1 center
  • Department of Intensive Care, Landspitali National University Hospital of Iceland — Reykjavik
Lithuania · 1 center
  • Vilnius University Hospital Santaros Clinics — Vilnius
Netherlands · 1 center
  • Department of Critical Care, University Medical Center Groningen — Groningen
Switzerland · 1 center
  • Department of Intensive Care, Inselspital — Bern

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. Furosemi PMID 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 protoc PMID 35898170

Identifiers

NCT: NCT04180397 · GODIF · 2024-512186-14-00 · 2019-004292-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗