Lowering sodium and chloride in diluent and maintenance IV fluids for critically ill adults
Effect of Reduced Sodium Chloride in Fluid Creep and Maintenance Fluids in Critically Ill Adults: A Randomized Controlled Trial
This trial will try using salt-free glucose for medication dilutions and a low-salt maintenance fluid to see if lowering sodium and chloride helps adults who need a prolonged stay in the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 640 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 4 sites (Antwerp and 3 other locations) |
| Trial ID | NCT07189091 on ClinicalTrials.gov |
What this trial studies
Adults admitted to participating intensive care units who are expected to require at least two more days of ICU care and substantial IV fluids will be assigned to one of two fluid strategies. The intervention uses glucose 5% for fluid creep and a low-salt maintenance solution (NaCl 0.3% in glucose 3.3%), while the comparison uses normal saline for creep and PlasmaLyte for maintenance. The study aims to reduce total sodium, chloride, and fluid exposure and track clinical outcomes such as fluid balance, organ support needs, and kidney function. This is a phase 4 interventional trial conducted at hospitals in Antwerp.
Who should consider this trial
Good fit: Adults (≥18) admitted to the ICU who are expected to need ICU care for at least two more days and to receive at least 300 mL of fluid creep or at least 1 L of maintenance fluid in the first 24 hours are ideal candidates.
Not a fit: Patients with contraindications to hypotonic fluids (for example traumatic brain injury, major stroke, intracranial hemorrhage), baseline hyponatremia below 131 mmol/L, or those admitted solely for cardiac decompensation-related fluid overload are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, lowering sodium and chloride from routine diluents and maintenance fluids could reduce fluid overload and electrolyte problems, potentially decreasing pulmonary edema, kidney injury, and time on organ support.
How similar studies have performed: Large randomized trials comparing saline to balanced crystalloids for resuscitation showed only small differences, and targeted reduction of sodium/chloride from fluid creep and maintenance is a relatively novel approach supported mainly by small studies and physiological data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. At least 18 years of age 2. Patients who are admitted to the ICU for medical or surgical emergencies, including complications of elective surgery 3. The treating physician expects the patient will still require ICU care in two days, indicating a severe or complex condition at enrollment 4. 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 Criteria: 1. 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. 2. Hyponatremia below 131 mmol/L at admission 3. 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. 4. Patient's death is deemed imminent and inevitable, admission for palliative care or admission solely for organ donation 5. Patient receiving chronic renal replacement therapy 6. Patients referred after a stay of more than 24 hours in another ICU 7. Patients randomized in CRUSADERS before 8. Patient is co-enrolled in an unapproved concomitant ICU-trial or in any trial with an intervention that affects fluid administration or fluid balance Additional exclusion criteria for the SALADIN nested substudy 1. Patients expected to require renal replacement therapy within 24 hours 2. Increased insensible fluid losses: burns, extensive wounds or skin defects or massive diarrhea,… 3. Patients without a urine catheter 4. Patients expected to require bladder irrigation within 24 hours 5. Patients on chronic treatment with loop or thiazide diuretics (including combination preparations)
Where this trial is running
Antwerp and 3 other locations
- ZAS Middelheim — Antwerp, Belgium (Not_yet_recruiting)
- ZAS Cadix — Antwerp, Belgium (Recruiting)
- Antwerp University Hopsital (UZA) — Edegem, Belgium (Not_yet_recruiting)
- ZAS Paflijn — Merksem, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Niels Van Regenmortel, MD, PhD — Ziekenhuis aan de Stroom (ZAS) Network of Hospitals
- Study coordinator: Petra Y Vertongen
- Email: petra.vertongen@uza.be
- Phone: +3238214404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.