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CReep and maintenance flUid Salt ADministration rEduction in cRitically ill adultS - (CRUSADERS)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520744-14-00
Enrollment
640
Registered
2025-06-13
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill patients

Brief summary

The primary endpoint of the CRUSADERS study is Days alive and without life support (DAWOLS) at 90 days after ICU admission.

Detailed description

Occurrence of moderate and severe hyponatremia, Occurrence of moderate and severe hypernatremia, Occurrence of moderate and severe hyperchloremia, Fluid retention and diuretic use, Occurrence of hyperglycemia and hypoglycemia, Acute kidney injury, Mechanical ventilation, Mortality and length of stay, Daily and cumulative sodium, chloride and glucose administration: daily and cumulative sodium, chloride and glucose administration from all sources except for non-study fluid creep and oral intake. For blood products, estimated values of sodium and chloride content are used., Fluid balance: Daily and cumulative fluid balance on ICU days, excluding (calculations of) insensible losses. From the moment RRT or IV loop diuretics are started, fluid balance data are analyzed separately from the patients without those interventions. Fluid balance assessments are discontinued from the ICU day when the urinary catheter is removed or bladder irrigation is initiated.

Interventions

DRUGViaflo
DRUGNaCl 0
DRUG3% w/v + Glucose 3
DRUG3% w/v Viaflo
DRUGoplossing voor intraveneuze infusie
DRUGGlucose 5 % w/v
DRUGoplossing voor infusie.

Sponsors

Universitair Ziekenhuis Antwerpen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the CRUSADERS study is Days alive and without life support (DAWOLS) at 90 days after ICU admission.

Secondary

MeasureTime frame
Occurrence of moderate and severe hyponatremia, Occurrence of moderate and severe hypernatremia, Occurrence of moderate and severe hyperchloremia, Fluid retention and diuretic use, Occurrence of hyperglycemia and hypoglycemia, Acute kidney injury, Mechanical ventilation, Mortality and length of stay, Daily and cumulative sodium, chloride and glucose administration: daily and cumulative sodium, chloride and glucose administration from all sources except for non-study fluid creep and oral intake. For blood products, estimated values of sodium and chloride content are used., Fluid balance: Daily and cumulative fluid balance on ICU days, excluding (calculations of) insensible losses. From the moment RRT or IV loop diuretics are started, fluid balance data are analyzed separately from the patients without those interventions. Fluid balance assessments are discontinued from the ICU day when the urinary catheter is removed or bladder irrigation is initiated.

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026