Reducing Sodium Chloride in Fluids to Improve Recovery for Critically Ill Adults in ICU A Randomized Study
Led by University Hospital, Antwerp · Updated on 2026-02-03
640
Participants Needed
4
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating two strategies for managing intravenous fluids in critically ill adults who need a prolonged stay in the intensive care unit ICU. These patients often receive large amounts of fluids that may contain more salt sodium and chloride than the body requires, which can cause fluid buildup and delay recovery. This phase IV, randomized, double-blind trial compares standard salt-rich fluids to fluids with reduced sodium and chloride to see if limiting salt intake can improve patient outcomes during ICU care.
Participants are randomly assigned to one of two groups. One group receives a sodium-chloride reduction strategy where medications and intravenous lines use glucose 5% solutions, and maintenance fluids contain low sodium chloride NaCl 0.3% in glucose 3.3%. The other group receives usual care with normal saline NaCl 0.9% for fluid creep and PlasmaLyte as maintenance fluid. The study fluids are administered throughout the ICU stay or until unavailable, with fluid volumes decided by the treating physician.
During the study, patients are closely monitored for survival and days free from life support such as ventilators or dialysis over 90 days. Researchers assess electrolyte imbalances, fluid balance, kidney function, time on mechanical ventilation, and lengths of ICU and hospital stay. A nested substudy involves detailed monitoring of sodium, chloride, and water handling through blood tests, urine collection, body weight, and bioimpedance. The trial aims to provide evidence on whether reducing sodium and chloride in these fluids improves recovery in critically ill adults.
CONDITIONS
Brief Title
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Research Team
P
Petra Y Vertongen
L
Leen Ameryckx
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Admitted to the ICU for medical or surgical emergencies, including complications of elective surgery
Expected by the treating physician to require ICU care for more than 2 days
Expected to receive at least 300 mL of fluid creep or at least 1 liter of maintenance fluid within the first 24 hours after inclusion
You will not qualify if you...
Contraindication to hypotonic fluids due to risk of brain edema (e.g., traumatic brain injury, major stroke, intracranial hemorrhage, meningoencephalitis, intracranial malignancies)
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 care
Imminent death, admission for palliative care, or admission solely for organ donation
Receiving chronic renal replacement therapy
Referred after more than 24 hours in another ICU
Previously randomized in this trial
Co-enrolled in an unapproved ICU trial or any trial affecting fluid administration or balance
Additional SALADIN substudy exclusions include expected renal replacement therapy within 24 hours, increased insensible fluid losses, no urine catheter, expected bladder irrigation within 24 hours, or chronic treatment with loop or thiazide diuretics
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Throughout the ICU stay or until study fluids are no longer available (minimum 28 days after randomization)
Participants receive either a sodium-chloride reduction strategy or a standard isotonic fluid strategy during their ICU stay to manage fluid and electrolyte support while minimizing sodium and chloride exposure.
Daily administration during ICU stay; visits coincide with ICU care
Follow-up
Duration - Up to 90 days after ICU admission
Participants are followed for outcomes including survival, life support dependence, and kidney function up to 90 days after ICU admission.
Periodic assessments until day 90
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Fluid-induced harm in the hospital: look beyond volume and start considering sodium. From physiology towards recommendations for daily practice in hospitalized adults.
Niels Van Regenmortel, Lynn Moers, Thomas Langer...
Insidious Harm of Medication Diluents as a Contributor to Cumulative Volume and Hyperchloremia: A Prospective, Open-Label, Sequential Period Pilot Study.
Carolyn A Magee, Melissa L Thompson Bastin, Melanie E Laine...
The impact of intravenous isotonic and hypotonic maintenance fluid on the risk of delirium in adult postoperative patients: retrospective before-after observational study.
Effect of sodium administration on fluid balance and sodium balance in health and the perioperative setting. Extended summary with additional insights from the MIHMoSA and TOPMAST studies.
Niels Van Regenmortel, Thomas Langer, Tim De Weerdt...
Conservative fluid management or deresuscitation for patients with sepsis or acute respiratory distress syndrome following the resuscitation phase of critical illness: a systematic review and meta-analysis.
Jonathan A Silversides, Emmet Major, Andrew J Ferguson...
Addressing the inadvertent sodium and chloride burden in critically ill patients: a prospective before-and-after study in a tertiary mixed intensive care unit population.