Clinical trial • Not applicable • Cardiology|Other

Furosemide (FUROSEMIDE PH. EUR.) for Fluid overload

Not applicable trial of Furosemide (FUROSEMIDE PH. EUR.) for Fluid overload.

Overview

Trial Therapeutic Area
Cardiology|Other
Trial Disease
Fluid overload
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-08-2024
First CTIS Authorization Date
05-09-2024

Trial design

Randomised, furosemide (intravenous infusion) versus placebo (sodium chloride 0.9% for intravenous infusion). product entries list furosemide with max daily dose amount 1500 mg (as per product metadata).-controlled Not applicable trial across 20 sites in Netherlands, Sweden, Denmark and others.

Randomised
Yes
Comparator
Furosemide (intravenous infusion) versus placebo (sodium chloride 0.9% for intravenous infusion). Product entries list furosemide with max daily dose amount 1500 mg (as per product metadata).
Target Sample Size
950
Trial Duration For Participant
365

Eligibility

Recruits 950 Vulnerable population selected: includes incapacitated adult ICU patients. The documentation includes informed consent procedures for incapacitated patients (e.g. 'L1_ICF_Initially_Incapacitated_Patient'), legal representative consent forms and deferred consent procedures (e.g. 'L1_Informed consent form where legal representive has given deferred consent', 'L1_ICF_ Legal_representative'). Consent must follow the model approved for the specific trial site; if consent is not obtainable this is an exclusion..

Pregnancy Exclusion
fertile women (women < 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG;
Vulnerable Population
Vulnerable population selected: includes incapacitated adult ICU patients. The documentation includes informed consent procedures for incapacitated patients (e.g. 'L1_ICF_Initially_Incapacitated_Patient'), legal representative consent forms and deferred consent procedures (e.g. 'L1_Informed consent form where legal representive has given deferred consent', 'L1_ICF_ Legal_representative'). Consent must follow the model approved for the specific trial site; if consent is not obtainable this is an exclusion.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- Known allergy to furosemide or sulphonamides\n- Known pre-hospitalisation advanced chronic kidney disease (eGFR < 30 mL/minute/1.73 m2 or chronic renal replacement therapy)\n- Ongoing renal replacement therapy\n- Anuria for ≥ 6 hours\n- Rhabdomyolysis with indication for forced diuresis\n- Ongoing life-threatening bleeding\n- Acute burn injury of more than 10 % of the body surface area\n- Severe dysnatraemia (p-Na < 120 or > 155 mmol/l)\n- Severe hepatic failure\n- Patients undergoing compulsory treatment\n- Fertile women (women < 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG\n- Consent not obtainable as per the model approved for the specific trial site."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The number of days alive and out of hospital at day 90","definition_or_measurement_approach":"Number of days alive and out of hospital at day 90; measured as the days alive and out of hospital counted from inclusion/randomisation to day 90."}

Secondary endpoints

  • {"endpoint_text":"- All-cause mortality at day 90","definition_or_measurement_approach":"All-cause mortality measured at day 90 post-randomisation."}
  • {"endpoint_text":"- days alive without life support at day 90","definition_or_measurement_approach":"Number of days alive and free of life-support interventions up to day 90."}
  • {"endpoint_text":"- number of participants with one or more serious adverse events and serious adverse reactions at day 90","definition_or_measurement_approach":"Count of participants experiencing one or more serious adverse events or serious adverse reactions assessed up to day 90."}
  • {"endpoint_text":"- all-cause mortality at 1 year","definition_or_measurement_approach":"All-cause mortality assessed at 1 year post-randomisation."}
  • {"endpoint_text":"- health-related quality of life at 1 year assessed by the EQ-5D-5L and EQ-VAS scores","definition_or_measurement_approach":"Health-related quality of life measured at 1 year using EQ-5D-5L and EQ-VAS instruments."}
  • {"endpoint_text":"- participants subjective assessment of their quality of life at 1 year (unacceptable/neutral/acceptable)","definition_or_measurement_approach":"Participant-reported subjective assessment of quality of life at 1 year categorized as unacceptable/neutral/acceptable."}
  • {"endpoint_text":"- Cognitive function after 1 year assessed by the Montreal Cognitive Assessment test (MoCA 5 min)","definition_or_measurement_approach":"Cognitive function measured at 1 year using the MoCA 5-minute test."}

Recruitment

Planned Sample Size
950
Recruitment Window Months
90
Consent Approach
Adult participants (≥18 years). For incapacitated patients consent procedures include obtaining consent from a legal representative and use of deferred consent where approved at the specific site. Multiple informed consent documents are provided (patient information and consent forms, legal representative forms, deferred consent forms). Site-specific consent models apply. Documents available in multiple languages (e.g. English, Dutch, Czech, Lithuanian, Swedish, Danish) as indicated by the submitted information/ICF documents.

Geography

Total Number Of Sites
20
Total Number Of Participants
950

Netherlands

Latest Decision Or Authorization Date
02-02-2025
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Department of Intensive Care
Principal Investigator Name
Frederik Eric Keus
Principal Investigator Email
f.keus@umcg.nl
Contact Person Name
Frederik Eric Keus
Contact Person Email
f.keus@umcg.nl
Number Of Participants
50

Sweden

Latest Decision Or Authorization Date
31-01-2025
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Soedersjukhuset AB
Department Name
Department of Intensive Care
Principal Investigator Name
Rebecka Rubenson Wahlin
Principal Investigator Email
rebecka.rubenson-wahlin@regionstockholm.se
Contact Person Name
Rebecka Rubenson Wahlin
Number Of Participants
50

Denmark

Latest Decision Or Authorization Date
28-01-2025
Number Of Sites
14
Number Of Participants
750

Sites

Site Name
Gentofte Hospital
Department Name
Department of Intensive Care
Contact Person Name
Camilla Tofte Eschen
Site Name
Region Midtjylland (Hospitalsparken 15, Herning)
Department Name
Department of Intensive Care
Contact Person Name
Thomas Tværmose Troelsen
Contact Person Email
thotro@rm.dk
Site Name
Copenhagen University Hospital (Ringvej 75, Herlev)
Department Name
Intensive Care Department
Contact Person Name
Anne Sofie Andreasen
Site Name
Odense University Hospital
Department Name
Department of Intensive Care
Contact Person Name
Louise Gramstrup Nielsen
Site Name
Region Sjaelland (Lykkebaekvej 1, Koege)
Department Name
Department of Intensive Care
Contact Person Name
Lars Nebrich
Contact Person Email
lnec@regionsjaelland.dk
Site Name
Nordsjaellands Hospital
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Sine Wichmann
Contact Person Email
sine.wichmann@regionh.dk
Site Name
Regionshospital Nordjylland
Department Name
Department of Intensive Care
Contact Person Name
Kjeld Asbjørn Jensen Damgaard
Contact Person Email
kad@rn.dk
Site Name
Region Midtjylland (Skovlyvej 15, Randers)
Department Name
Department of Intensive Care
Contact Person Name
Marianne Lauridsen Vang
Contact Person Email
marivang@rm.dk
Site Name
Rigshospitalet
Department Name
Department of Intensive Care - 4131
Contact Person Name
Anders Bastiansen
Contact Person Email
anders.bastiansen@regionh.dk
Site Name
Region Syddanmark
Department Name
Department of Intensive Care
Contact Person Name
Thomas Strøm
Contact Person Email
thomas.stroem@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Intensive Care
Contact Person Name
Meike Tomesch Behzadi
Contact Person Email
meike.tomesch@rn.dk
Site Name
Lillebaelt Hospital
Department Name
Department of Intensive Care
Contact Person Name
Anne Craveiro Brøchner
Site Name
Region Midtjylland (Heibergs Alle 4, Viborg)
Department Name
Department of Intensive Care
Contact Person Name
Christoffer Grant Sølling
Contact Person Email
chrisl@rm.dk
Site Name
Region Sjaelland (Sygehusvej 10, Roskilde)
Department Name
Department of Intensive Care
Contact Person Name
Thomas Hildebrandt
Contact Person Email
thi@regionsjaelland.dk

Czechia

Latest Decision Or Authorization Date
15-09-2025
Number Of Sites
3
Number Of Participants
75

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika anesteziologie, resuscitace a intenzivní medicíny
Principal Investigator Name
Jan Máca
Principal Investigator Email
jan.maca@fno.cz
Contact Person Name
Jan Máca
Contact Person Email
jan.maca@fno.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Klinika anesteziologie, resuscitace a int. péče (KARIP)
Principal Investigator Name
Petr Píza
Principal Investigator Email
petr.piza@ikem.cz
Contact Person Name
Petr Píza
Contact Person Email
petr.piza@ikem.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
Klinika anesteziologie, resuscitace a intenzivní medicíny
Principal Investigator Name
Marek Nalos
Principal Investigator Email
nalosm@fnplzen.cz
Contact Person Name
Marek Nalos
Contact Person Email
nalosm@fnplzen.cz

Lithuania

Latest Decision Or Authorization Date
09-01-2026
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Anesteziologijos, intensyvios terapijos ir skausmo gydymo centras
Principal Investigator Name
Ieva Jovaišienė
Principal Investigator Email
Ieva.Jovaisiene@santa.lt
Contact Person Name
Ieva Jovaišienė
Contact Person Email
Ieva.Jovaisiene@santa.lt
Number Of Participants
25

Sponsor

Primary sponsor

Full Name
Region Hovedstaden
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Furosemide
Active Substance
Furosemide (FUROSEMIDE PH. EUR.)
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised (product entries include SmPC documents)
Maximum Dose
1500 mg per day (maxDailyDoseAmount as per product metadata)
Investigational Product Name
Placebo (sodium chloride 0.9% for intravenous infusion)
Modality
Other
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Placebo (sodium chloride 0.9%) available/authorized for use on-site in some countries as described
Investigational Product Name
Amiloride hydrochloride, furosemide (combination product entry)
Active Substance
Amiloride hydrochloride; furosemide
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised (product metadata present)
Maximum Dose
1500 mg per day (furosemide component maxDailyDoseAmount as per product metadata)

Related trials

Other published trials that may interest you.