Goal directed fluid removal in critically ill patients with fluid overload.

Phase 1

• Conditions: Treatment of fluid overload in critically ill adult patients in intensive care unit.; MedDRA version: 22.1Level: LLTClassification code 10015766Term: Extracellular fluid increasedSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: LLTClassification code 10016808Term: Fluid retention in tissuesSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 26.1Level: LLTClassification code 10022608Term: Interstitial fluid increasedSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 24.1Level: LLTClassification code 10033303Term: OverhydrationSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: LLTClassification code 10030102Term: Oedema generalisedSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 20.1Level: LLTClassification code 10034611Term: Peripheral oedemaSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-004292-40-IS
• Lead Sponsor: Department of Anesthesia and Intensive Care Medicine, Nordsjællands hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-02
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1041

Inclusion Criteria

All of the parameters must be met:

•Acute admission to the ICU.
•Age = 18 years of age.
•Fluid accumulation estimated according to daily fluid charts, the cumulative fluid balance, development in body weight, and clinical examination
corresponding = 5% of ideal body weight.
•Clinical stable assessed by the clinicians (minimum criteria: MAP > 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline
and lactate < 4,0 mmol/L).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 831

Exclusion Criteria

•Known allergy to furosemide or sulphonamides.
•Known pre-hospitalization advanced chronic kidney disease (eGFR<30 mL/minute/1.73 m2 or chronic renal replacement therapy).
•Ongoing renal replacement therapy
•Anuria for = 6 hours
•Rhabdomyolysis with indication for forced diuresis
•Ongoing life-threatening bleeding.
•Acute burn injury of more than 10 % of the body surface area.
•Severe dysnatremia (p-Na < 120 mmol/L or >155 mmol/l).
•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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified