Goal directed fluid removal in critically ill patients with fluid overload

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

24 Aug 2020 → ongoing

Decision date (initial)

2025-09-15

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-512186-14-00

EudraCT number

2019-004292-40

ClinicalTrials.gov

NCT04180397

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety

To assess the benefits and harms of goal-directed fluid removal with furosemide versus placebo on patient-important outcome measures in adult ICU patients with moderate to severe fluid overload. The primary objective is to determine if forced fluid removal with furosemide compared with placebo (spontaneous fluid excretion) will increase the number of days alive and out of hospital at day 90 day

Conditions and MedDRA coding

Fluid overload/fluid accumulation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. All the following parameters must be met: acute admission to the ICU, 18 years of age or above, clinically 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), and fluid accumulation estimated according to daily fluid balance, the cumulative fluid balance, development in body weight, and clinical examination corresponding to at least 5% of ideal body wight

Exclusion criteria 1

1. Known allergy to furosemide or sulphonamides; known pre-hospitalisation 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 dysnatraemia (p-Na < 120 or > 155 mmol/l); severe hepatic failure; patients undergoing compulsory 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The number of days alive and out of hospital at day 90

Secondary endpoints 1

1. All-cause mortality at day 90; days alive without life support at day 90; number of participants with one or more serious adverse events and serious adverse reactions at day 90; all-cause mortality at 1 year; health-related quality of life at 1 year assessed by the EQ-5D-5L and EQ-VAS scores; participants subjective assessment of their quality of life at 1 year (unacceptable/neutral/acceptable); Cognitive function after 1 year assessed by the Montreal Cognitive Assessment test (MoCA 5 min)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Dyrehavevej 29

City

Hilleroed

Postcode

3400

Country

Denmark

Scientific contact point

Organisation

Nordsjaellands Hospital

Contact name

Sine Wichmann

Public contact point

Organisation

Nordsjaellands Hospital

Contact name

Sine Wichmann

Third parties 1

Locations

5 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 39 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications