A Phase 4 interventional study of Furosemide and Isotonic saline in Fluid Overload, sponsored by Morten H. Bestle. Recruiting at 29 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Morten H. Bestle · Phase 4, Interventional, and Treatment
Among 14 studies testing furosemide in Edema — 6 open to participants now, 6 under way, 1 of them phase 3. Furosemide · Edema.
Among the 14 studies testing furosemide in Edema, this one has the largest planned enrollment, is the only one that started in 2020, is one of 7 in phase 4, and was the 8th registered.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
Browse Edema studies →6 of the 14 studies testing furosemide in Edema are open now, in 12 countries. Recruiting first, the newest first:
University of Aarhus · Sites in Denmark
Stacy Johnson · Sites in United States
University of Florida · Sites in United States
Jose J Zaragoza, MD MSc · Sites in Mexico
Unity Health Toronto · Sites in Canada
By country, each count listing its studies:
Furosemide: first FDA approval 1966 (LASIX), first EMA approval 2026. What it is approved for, and how studies give it, is on its page →
Of the 56 Edema studies recruiting now, 34 (61%) set no upper age limit and 16 (29%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2020.
This study's planned enrollment of 1,000 is above the median of 52 across 401 interventional studies indexed under Edema.
Median enrollment 87 across the 14 interventional studies. Of the 7 that completed or were terminated, 1 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 14 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Morten H. Bestle as lead sponsor.
Morten H. Bestle has 1 study filed under Edema — fewer than ten, so there is no comparison to draw.
3 of the studies testing furosemide in Edema that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06979726University of FloridaGator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure | 2026-11-30 |
| NCT04180397Morten H. BestleControlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit. | 2027-04-30 |
| NCT07577596University of AarhusInfusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure | 2027-09-01 |
Among the 14 studies testing furosemide in Edema, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.
Inclusion Criteria: ALL below must be met.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bolus of 5-40 mg (0.5 - 4 ml) of furosemide iv at physicians discretion followed by infusion of furosemide. Infusion rate: 0-40 mg/hour. Starting rate: 20 mg/hour. The infusion is adjusted according effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.
Drug: Furosemide
Isotonic saline dosed the same way and by the same algorithm as for furosemide. Start bolus of 0.5-4 ml at physicians discretion. Infusion rate: 0 - 4 ml/hour. Infusion is started at 2 ml/hour and adjusted according to effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.
Drug: Isotonic saline
Furosemide 10 mg/ml for injection/infusion
Also known as: Furix
Isotonic saline used as placebo (injection/infusion)
Days alive and out of hospital
Days alive and out of hospital
Time frame: 90 days after randomization
All cause mortality
All cause mortality
Time frame: 90 days after randomization
Mortality and life support
Days alive without life support without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy)
Time frame: 90 days after randomization
Mortality 1 year
All cause mortality
Time frame: one year after randomization
Serious adverse events and reactions
Number of participants with one or more serious adverse events and serious adverse reactions
Time frame: 90 days
Health related quality of life
Measured using the European quality of Life 5D-5L questionnaire (5D-5L is the full name of the questionnaire). Index value of 1 represents full health and dead = 0. These value sets reflect the preferences of the general population. The European quality of life visual analogue scale is a self-reported assessment of the participant's health status. Scores on 100 = the best health you can imagine and 0 = the worst health you can imagine.
Time frame: 1 year after randomization
Cognitive function
Cognitive function assessed by the Montreal Cognitive Assessment score. Using the mini test for telephone interview. The test and scoring system will soon be published from Montreal Cognitive Assessment.
Time frame: 1 year after randomization
Health related quality of life
Subjective assessment (unacceptable, neutral, acceptable)
Time frame: 1 year after randomization
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Plan to share: Yes — will be made available on reasonable request after the primary results are published
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Started Aug 2020 (actual). Primary completion is estimated for Apr 2027, 80 months after the start.
Of 28 phase 4 interventional studies under Edema, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 74. This study's planned 80 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Furosemide