Lowering sodium and chloride in diluent and maintenance IV fluids for critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults admitted to participating intensive care units who are expected to require at least two more days of ICU care and substantial IV fluids will be assigned to one of two fluid strategies. The intervention uses glucose 5% for fluid creep and a low-salt maintenance solution (NaCl 0.3% in glucose 3.3%), while the comparison uses normal saline for creep and PlasmaLyte for maintenance. The study aims to reduce total sodium, chloride, and fluid exposure and track clinical outcomes such as fluid balance, organ support needs, and kidney function. This is a phase 4 interventional trial conducted at hospitals in Antwerp.

Why it matters

Who can join: the full rules

Inclusion criteria

1. At least 18 years of age
2. Patients who are admitted to the ICU for medical or surgical emergencies, including complications of elective surgery
3. The treating physician expects the patient will still require ICU care in two days, indicating a severe or complex condition at enrollment
4. 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:

1. 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.
2. Hyponatremia below 131 mmol/L at admission
3. 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.
4. Patient's death is deemed imminent and inevitable, admission for palliative care or admission solely for organ donation
5. Patient receiving chronic renal replacement therapy
6. Patients referred after a stay of more than 24 hours in another ICU
7. Patients randomized in CRUSADERS before
8. 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

1. Patients expected to require renal replacement therapy within 24 hours
2. Increased insensible fluid losses: burns, extensive wounds or skin defects or massive diarrhea,…
3. Patients without a urine catheter
4. Patients expected to require bladder irrigation within 24 hours
5. Patients on chronic treatment with loop or thiazide diuretics (including combination preparations)

Where it's running

• ZAS Cadix
  Antwerp, Belgium Recruiting
• ZAS Middelheim
  Antwerp, Belgium Not yet recruiting
• Antwerp University Hopsital (UZA)
  Edegem, Belgium Not yet recruiting
• ZAS Paflijn
  Merksem, Belgium Not yet recruiting

Study contacts

• Principal investigator: Niels Van Regenmortel, MD, PhD — Ziekenhuis aan de Stroom (ZAS) Network of Hospitals
• Study coordinator: Petra Y Vertongen
• Email: petra.vertongen@uza.be
• Phone: +3238214404

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.