Status:
RECRUITING
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Ziekenhuis aan de Stroom
Research Foundation Flanders
Conditions:
Critical Care, Intensive Care
Fluid Accumulation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is enrolling adult patients who require a prolonged stay in the intensive care unit (ICU). These patients often receive large amounts of intravenous fluids, which can contain more salt (sod...
Detailed Description
Critically ill patients admitted to the intensive care unit (ICU) often receive large volumes of intravenous fluids. Beyond resuscitation fluids, which have been extensively studied, two other sources...
Eligibility Criteria
Inclusion
- Inclusion criteria
- At least 18 years of age
- Patients who are admitted to the ICU for medical or surgical emergencies, including complications of elective surgery
- The treating physician expects the patient will still require ICU care in two days, indicating a severe or complex condition at enrollment
- The patient is expected to receive at least 300 mL of fluid creep or at least 1 liter of maintenance fluid according to study-arm during the first 24h after inclusion
- Exclusion Criteria:
- A contraindication to hypotonic fluids due to risk of brain edema (including traumatic brain injury, major stroke, intracranial/subarachnoid hemorrhage, meningoencephalitis, intracranial malignancies…), with the timing and clinical judgment left at the discretion of the treating physician.
- Hyponatremia below 131 mmol/L at admission
- Admission solely for treatment of fluid accumulation due to cardiac decompensation, without other acute medical conditions requiring ICU-level care. Note: Patients with heart failure as a comorbidity, those on chronic diuretic therapy, or presenting with edema/bilateral lung infiltrates due to other conditions (e.g., sepsis, pneumonia) are not excluded.
- Patient's death is deemed imminent and inevitable, admission for palliative care or admission solely for organ donation
- Patient receiving chronic renal replacement therapy
- Patients referred after a stay of more than 24 hours in another ICU
- Patients randomized in CRUSADERS before
- Patient is co-enrolled in an unapproved concomitant ICU-trial or in any trial with an intervention that affects fluid administration or fluid balance
- Additional exclusion criteria for the SALADIN nested substudy
- Patients expected to require renal replacement therapy within 24 hours
- Increased insensible fluid losses: burns, extensive wounds or skin defects or massive diarrhea,…
- Patients without a urine catheter
- Patients expected to require bladder irrigation within 24 hours
- Patients on chronic treatment with loop or thiazide diuretics (including combination preparations)
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT07189091
Start Date
September 1 2025
End Date
July 30 2028
Last Update
September 30 2025
Active Locations (4)
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1
ZAS Middelheim
Antwerp, Belgium, 2020
2
ZAS Cadix
Antwerp, Belgium, 2030
3
Antwerp University Hopsital (UZA)
Edegem, Belgium, 2650
4
ZAS Paflijn
Merksem, Belgium, 2170