Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07189091

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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

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