Actively Recruiting
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Led by University Hospital, Antwerp · Updated on 2026-02-03
640
Participants Needed
4
Research Sites
146 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Antwerp
Lead Sponsor
Z
Ziekenhuis aan de Stroom
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Admitted to the ICU for medical or surgical emergencies, including complications of elective surgery
- Expected by the treating physician to require ICU care for at least two more days
- Expected to receive at least 300 mL of fluid creep or 1 liter of maintenance fluid in 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 ICU-level conditions
- Imminent and inevitable death, palliative care admission, or admission solely for organ donation
- Receiving chronic renal replacement therapy
- Referred after more than 24 hours in another ICU
- Previous participation in CRUSADERS trial
- Co-enrollment in unapproved ICU trials or any trial affecting fluid administration or balance
- For SALADIN substudy: expected renal replacement therapy within 24 hours, increased insensible fluid losses (burns, extensive wounds, massive diarrhea), no urine catheter, expected bladder irrigation within 24 hours, chronic treatment with loop or thiazide diuretics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
ZAS Middelheim
Antwerp, Belgium, 2020
Not Yet Recruiting
2
ZAS Cadix
Antwerp, Belgium, 2030
Actively Recruiting
3
Antwerp University Hopsital (UZA)
Edegem, Belgium, 2650
Not Yet Recruiting
4
ZAS Paflijn
Merksem, Belgium, 2170
Not Yet Recruiting
Research Team
P
Petra Y Vertongen
CONTACT
L
Leen Ameryckx
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here