NIPH Clinical Trials Search

Synbiotics and Post-Intensive Care Syndrome in Sepsis Patients

Basic Information

Recruitment status	Suspended
Health condition(s) or Problem(s) studied	sepsis
Date of first enrollment	28/04/2025
Target sample size	780
Countries of recruitment
Study type	Interventional
Intervention(s)	Administer a synbiotic product to the patient

Outcome(s)

Primary Outcome

Incidence of post-intensive care syndrome (PICS) within 30 days after ICU discharge, including physical, cognitive, and psychological impairments

Secondary Outcome

Severity of post-intensive care syndrome (PICS) Length of ICU stay Length of hospital stay 28-day mortality rate Incidence of infections (e.g., ventilator-associated pneumonia [VAP], catheter-related bloodstream infection [CRBSI], urinary tract infection) Duration of antibiotic use Gastric residual volume Bowel conditions (frequency and amount of defecation, stool characteristics) Changes in blood inflammatory markers (e.g., C-reactive protein [CRP])

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	Adult patients diagnosed with sepsis and admitted to the ICU, in whom enteral nutrition was initiated within 24 hours of ICU admission
Exclude criteria	Patients who died within 24 hours after ICU admission Pregnant or breastfeeding women Patients with conditions that contraindicate enteral nutrition (intestinal obstruction, gastrointestinal perforation) Patients who had been continuously using synbiotic products prior to the study Patients with a known allergy to synbiotic products If the patient (or their legal representative) refuses to participate in the study