This study has been transitioned to CTIS with ID 2024-512186-14-00 check the CTIS register for the current data. To assess benefits and harms of goal directed fluid removal with furosemide versus placebo on patient-important outcome measures in…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
vochtoverbelasting bij acute opgenomen intensive care patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is days alive and out of hospital at day 90.
Secondary outcome
Secondary outcomes are days alive at day 90 without life support, all-cause
mortality at day 90, and all-cause mortality 1 year after randomisation, and
serious adverse events and reactions in the ICU
Background summary
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. This is especially true in patients with
acute kidney injury (AKI), since they often have impaired ability to excrete
salt and water. Several observational studies indicate a detrimental effect of
fluid overload in different clinical settings, including patients with AKI. 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.
Study objective
This study has been transitioned to CTIS with ID 2024-512186-14-00 check the CTIS register for the current data.
To assess benefits and harms of goal directed fluid removal with furosemide
versus placebo on patient-important outcome measures in adult ICU patients with
fluid overload.
Study design
An investigator-initiated, international, multi-centre, centrally randomised,
blinded, stratified, parallel-group trial of furosemide versus placebo in adult
ICU patients with moderate-to-severe fluid overload.
Intervention
Intervention: The experimental intervention is goal directed fluid removal
aimed at neutral fluid balance achieved as fast as possible and maintained
throughout the entire ICU stay. Neutral fluid balance is achieved by furosemide
according to a specific algorithm to achieve the therapeutic goal (negative
fluid balance >= 1 ml/kg/h) with a maximum infusion rate of 40 mg/h.
Control intervention will be matching placebo (saline), which will be
administered according to the same goals and algorithm.
Safety variables are monitored continuously and if there is indication of
inadequate circulation a resuscitation algorithm can be activated.
Study burden and risks
Rapid resolution of severe fluid overload and restoration of normo-volaemia
will normalise the structure of organs suffering from interstitial oedema and
facilitate oxygen delivery and functionality. Furthermore, fluid removal with
diuretics will lead to a reduction in total body sodium and chloride. However,
if the rate of fluid removal exceeds the refilling capacity of compensatory
fluid movement from the extravascular compartment, the preload will be
compromised, and the mean arterial pressure will decline. This might lead to
progressive loss of renal function due to a reduction in RBF and GFR or other
non-renal effects.
Dyrehavevej 29
Hillerød 3400
DK
Dyrehavevej 29
Hillerød 3400
DK
Listed location countries
Age
Inclusion criteria
All of the following criteria must be fulfilled:
• Acute admission to the Intensive Care Unit.
• Age >= 18 years of age.
• Fluid overload defined as a positive cumulative fluid balance (according to
the daily fluid charts) corresponding >= 5 % of ideal body weight (calculated
as: 22 x (height in meters)^2). If possible, all fluids administered before
admission to the ICU are to be included in the calculation of cumulative fluid
balance.
• Clinical stable defined as Mean Arterial Pressure > 50 mmHg and maximum
infusion of 0.20 microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/L.
Exclusion criteria
• Known allergy to furosemide or sulphonamides.
• Known pre-hospitalisation advanced chronic kidney disease (eGFR < 30
mL/minute/1.73 m2 or chronic RRT).
• Ongoing RRT.
• Anuria for >= 6 hours.
• Rhabdomyolysis with indication for forced diuresis
• Ongoing life-threatening bleeding as these patients need specific fluid/blood
product strategies.
• Acute burn injury of more than 10 % of the body surface area as these
patients need a specific fluid strategy.
• Severe dysnatraemia (p-Na < 120 or > 155 mmol/l) as these patients need a
specific fluid strategy.
• 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-512186-14-00 |
| EudraCT | EUCTR2019-004292-40-NL |
| ClinicalTrials.gov | NCT04180397 |
| CCMO | NL77405.042.21 |