The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN): A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This multicenter, randomized controlled trial aims to evaluate whether early initiation of supplemental parenteral nutrition (SPN) (on day 4 of ICU admission) compared to late initiation (on day 8) can reduce 28-day all-cause mortality in critically ill patients. Secondary objectives include assessing the effects of early SPN on long-term functional outcomes (2-year EQ-5D-5L scores), mortality at various timepoints (ICU, 28-day, 90-day, 180-day, and 2-year), ICU length of stay, serum prealbumin levels (days 8 and 28), skeletal muscle measurements (diaphragm thickness, biceps, quadriceps, and rectus femoris cross-sectional area), incidence of ICU-acquired infections, adverse events (e.g., hyperglycemia, hypoglycemia, dyslipidemia, liver dysfunction), and ventilator-free days within 28 days. Eligible patients are adults (≥18 years) with at least one organ failure (SOFA score ≥2) within 24 hours of ICU admission, expected to remain in the ICU for \>72 hours, and unable to reach 50% of caloric target via enteral nutrition (EN) within the first 72 hours. A total of 946 patients will be enrolled and randomized to receive either early SPN (day 4) or late SPN (day 8) in addition to standard EN. Follow-up will include in-hospital assessments and telephone follow-ups at 28, 90, 180 days, and 2 years. The study hypothesizes that early SPN may improve short-term survival and nutritional/muscle status, though its impact on long-term quality of life remains to be determined.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Failure of one or more organ systems within 24 hours of ICU admission, defined as Sequential Organ Failure Assessment (SOFA) score ≥ 2 in any single organ system

• Expected ICU stay \> 72 hours

• Able to initiate early enteral nutrition (EN) within 48 hours of ICU admission

Locations
Other Locations
China
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
yanhua li
liyanhua@jiu.edu.cn
86-15804301738
Backup
youquan wang
wangyq20@mails.jlu.edu.cn
86-15584299391
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2029-07-20
Participants
Target number of participants: 946
Treatments
Experimental: Early SPN Group
Patients in this group will receive supplemental parenteral nutrition (SPN) starting on day 4 after ICU admission, in addition to standard enteral nutrition (EN).
Active_comparator: Late SPN Group
Patients in this group will receive SPN starting on day 8 after ICU admission, in addition to standard EN.
Related Therapeutic Areas
Sponsors
Leads: Dong Zhang

This content was sourced from clinicaltrials.gov