Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04180397

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

Led by Morten H. Bestle · Updated on 2025-02-06

1000

Participants Needed

24

Research Sites

395 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

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.

CONDITIONS

Official 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 if possible
  • Clinically stable with mean arterial pressure over 50 mmHg, noradrenaline infusion no higher than 20 microgram/kg/min, and lactate below 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 less than 30 mL/min/1.73 m2 or chronic renal replacement therapy)
  • Currently receiving renal replacement therapy
  • Anuria lasting more than 6 hours
  • Rhabdomyolysis requiring forced diuresis
  • Ongoing life-threatening bleeding
  • Acute burn injury affecting more than 10% of body surface
  • Severe sodium imbalance (p-Na less than 120 or greater than 155 mmol/L)
  • Severe liver failure
  • Patients under forced treatment
  • Fertile women under 50 years with positive pregnancy test (urine or plasma hCG)
  • Consent not obtainable as per trial site model

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

Department of Intensive Care, Liverpool Hospital

Sydney, Australia

Not Yet Recruiting

2

Department of Intensive Care, Sygehus Sønderjylland Aabenraa

Aabenraa, Denmark

Actively Recruiting

3

Departmen of Intensive Care

Aalborg, Denmark, 9000

Actively Recruiting

4

Department of Intensive Care, Aarhus University Hospital

Aarhus, Denmark

Terminated

5

Department of Intensive Care, Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

6

Departement of Intensive Care, Gentofte Hospital

Gentofte Municipality, Denmark

Terminated

7

Department of Intensive Care, Herlev Hospital

Herlev, Denmark, 2730

Actively Recruiting

8

Department of Intensive Care, Regionshospital Gødstrup

Herning, Denmark, 7400

Actively Recruiting

9

Department of Intensive Care, Nordsjællands hospital

Hillerød, Denmark, 3400

Actively Recruiting

10

Department of Intensive Care, Regionshospital Nordjylland Hjørring

Hjørring, Denmark

Actively Recruiting

11

Department of Intensive Care

Kolding, Denmark, 6000

Actively Recruiting

12

Department of Intensive Care, Zealand University hospital

Køge, Denmark, 4600

Actively Recruiting

13

Department of Intensive Care

Odense, Denmark, 5000

Actively Recruiting

14

Department of Intensive Care, Regionshospitalet Randers

Randers, Denmark, 8930

Actively Recruiting

15

Department of Intensive Care, University Hospital Zealand, Roskilde

Roskilde, Denmark

Actively Recruiting

16

Department of Intensive Care

Vejle, Denmark, 7100

Withdrawn

17

Regionshospitalet Viborg

Viborg, Denmark, 8800

Actively Recruiting

18

Department of Intensive Care, Tampere University Hospital

Tampere, Finland, 33520

Terminated

19

Department of Intensive Care

Turku, Finland

Terminated

20

Department of Intensive Care, Landspitali National University Hospital of Iceland

Reykjavik, Iceland

Terminated

21

Department of Critical Care, University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

22

Department of Intensive Care, Ålesund Sjukehus

Ålesund, Norway

Terminated

23

Department of Intensive Care, Stavanger University Hospital

Stavanger, Norway, 4068

Terminated

24

Department of Intensive Care, Inselspital

Bern, Switzerland

Actively Recruiting

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Research Team

S

Sine Wichmann, MD

CONTACT

M

Morten Bestle, MD

CONTACT

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