Fluid overload/fluid accumulation
Conditions
Brief summary
The number of days alive and out of hospital at day 90
Detailed description
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)
Interventions
DRUGIn Denmark and The Netherlands
DRUGthe trial is approved with trial drugs produced by the capital region pharmacy in Denmark which included both placebo and furosemide. the placebo is sodium chloride 0.9% for intravenous infusion. the sIMPD is up-loaded in the section below. Sweden has got the trial approved with sodium chloride 0.9% available in their departments with marketing authorisation. They perform the blinding and preparation of the trial drug on-site
DRUGfor that reason the sIMPD is only relevant for Denmark and The Netherlands.
DRUGFurosemide
DRUGFUROSEMIDE
Sponsors
Region Hovedstaden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days alive and out of hospital at day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Czechia, Denmark, Lithuania, Netherlands, Sweden
Outcome results
None listed