Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07189091

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

Led by University Hospital, Antwerp · Updated on 2026-02-03

640

Participants Needed

4

Research Sites

13 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

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

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 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
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 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

AI-Screening

AI-Powered Screening

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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

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

L

Leen Ameryckx

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

Association between days alive without life support/out of hospital and health-related quality of life.

Anders Granholm, Olav Lilleholt Schjørring, Aksel Karl Georg Jensen...

https://pubmed.ncbi.nlm.nih.gov/36915265

Maintenance fluid therapy and fluid creep impose more significant fluid, sodium, and chloride burdens than resuscitation fluids in critically ill patients: a retrospective study in a tertiary mixed ICU population.

Niels Van Regenmortel, Walter Verbrugghe, Ella Roelant...

https://pubmed.ncbi.nlm.nih.gov/29589054

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...

https://pubmed.ncbi.nlm.nih.gov/33999276

154 compared to 54 mmol per liter of sodium in intravenous maintenance fluid therapy for adult patients undergoing major thoracic surgery (TOPMAST): a single-center randomized controlled double-blind trial.

Niels Van Regenmortel, Steven Hendrickx, Ella Roelant...

https://pubmed.ncbi.nlm.nih.gov/31576437

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...

https://pubmed.ncbi.nlm.nih.gov/27734109

Fluid overload is an independent risk factor for acute kidney injury in critically Ill patients: results of a cohort study.

Nawal Salahuddin, Mustafa Sammani, Ammar Hamdan...

https://pubmed.ncbi.nlm.nih.gov/28143505

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.

Shailesh Bihari, Shivesh Prakash, Simon Potts...

https://pubmed.ncbi.nlm.nih.gov/30482136

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...

https://pubmed.ncbi.nlm.nih.gov/29727367

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...

https://pubmed.ncbi.nlm.nih.gov/34798374