CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS (NCT07189091) | Clinical Trial Compass
RecruitingPhase 4
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Belgium640 participantsStarted 2025-10-07
Plain-language 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 (sodium and chloride) than the body normally needs. Extra salt and water can build up in the body and may delay recovery.
The study will test two strategies:
Fluid creep: These are fluids used to dilute medications or keep intravenous lines open. Usually, the choice is based on habit. In the intervention group, a salt-free glucose 5% solution will be used (if the responsible pharmacist confirms it is compatible with the medication).
Maintenance fluids: These fluids cover daily needs for water and electrolytes. In the intervention group, a lower-salt solution (NaCl 0.3% in glucose 3.3%) will be given, with volume decided by the treating physician.
The comparison group will receive usual care: NaCl 0.9% (commonly called "normal saline") for fluid creep, and an isotonic solution (PlasmaLyte) for maintenance fluids.
The main outcome is the number of days patients are alive and free of life support (such as ventilator or dialysis) during the first 90 days. Other outcomes include abnormal sodium, chloride, or glucose levels, fluid balance and need for diuretics, kidney injury, use of dialysis, time on the ventilator, survival, and length of ICU and hospital stay.
A smaller substudy (SALADIN) will measure in detail how the body handles sodium, chloride, and water using additional calculation on blood tests, urine collections, body weight, and bioimpedance analysis
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Days alive and without life support at day 90 (DAWOLS90)
Timeframe: From admission until day 90 counted from ICU admission (= Day 1)
✕. 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