About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Glucose 5% for fluid creep
- NaCl 0.9% (normal saline) for fluid creep
- PlasmaLyte as maintenance fluid
- NaCl 0.3% in glucose 3.3% as maintenance fluid
Treatment groups
Sponsors and collaborators
University Hospital, Antwerp
Lead sponsor
Ziekenhuis aan de Stroom
Collaborator
Research Foundation Flanders
Collaborator