CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS

Recruiting now · Phase 4

Conditions studied: Critical Care, Intensive Care, Fluid Accumulation, Fluid and Electrolyte Imbalance, Critical Illness, Fluid Balance Outcomes

In brief

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

Key facts

Study ID

NCT07189091

Run by

University Hospital, Antwerp

People needed

640

Starts

2025-10-07

Expected to finish

2028-07-30

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• ZAS Cadix — Antwerp, Belgium (enrolling)
• ZAS Middelheim — Antwerp, Belgium
• Antwerp University Hopsital (UZA) — Edegem, Belgium
• ZAS Paflijn — Merksem, Belgium

Full record on ClinicalTrials.gov

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