RecruitingPhase 4NCT07189091

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

Effect of Reduced Sodium Chloride in Fluid Creep and Maintenance Fluids in Critically Ill Adults: A Randomized Controlled Trial

Sponsor

University Hospital, Antwerp

Enrollment

640 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria13

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
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)

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Interventions

DRUGGlucose 5% for fluid creep

* Medications, including concentrated electrolytes, are dissolved in glucose 5% except when another solvent is mandatory according to the responsible pharmacist. * Infusions to keep intravenous lines open are glucose 5%

DRUGNaCl 0.9% (normal saline) for fluid creep

* Medications, including concentrated electrolytes, are dissolved in NaCl 0.9% except when another solvent is mandatory according to the responsible pharmacist. * All infusions to keep intravenous lines open are NaCl 0.9%.

DRUGPlasmaLyte as maintenance fluid

* Type: Maintenance fluid is PlasmaLyte. Potassium chloride or potassium phosphate can be added (or administered separately) whenever deemed necessary. * Rate: at the discretion of the treating physician, typically 25-30 ml/kg of body weight with a maximum of 100 ml/hour, accounting for concomitant fluid sources such as nutrition and fluid creep. It is allowed to prescribe a higher volume of study maintenance fluids to include replacement if both study fluids are considered appropriate.

DRUGNaCl 0.3% in glucose 3.3% as maintenance fluid

* Type: maintenance fluid is NaCl 0.3% in glucose 3.3%. Potassium chloride or potassium phosphate can be added (or administered separately) at the discretion of the treating physician whenever necessary. * Rate: at the discretion of the treating physician, typically 25-30 ml/kg of body weight with a maximum of 100 ml/hour, accounting for concomitant fluid sources such as nutrition and fluid creep. It is allowed to prescribe a higher volume of study maintenance fluids to include replacement if both study fluids are considered appropriate