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/36915265Actively Recruiting
Led by University Hospital, Antwerp · Updated on 2026-02-03
640
Participants Needed
4
Research Sites
13 weeks
Total Duration
U
University Hospital, Antwerp
Lead Sponsor
Z
Ziekenhuis aan de Stroom
Collaborating Sponsor
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
CReep and Maintenance flUid Sodium Chloride ADministration rEduction in cRitically Ill adultS
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
P
Petra Y Vertongen
L
Leen Ameryckx
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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