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The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN)

NCT07085455 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 946

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Organ Dysfunction
  • Enteral Nutrition Intolerance
  • Inadequate Nutritional Intake

Interventions

DIETARY_SUPPLEMENT

Early Supplemental Parenteral Nutrition (SPN)

SPN is initiated on ICU day 4 if enteral nutrition remains \<50% of the target caloric requirement. Nutrition support is guided by protocol

DIETARY_SUPPLEMENT

Late Supplemental Parenteral Nutrition (SPN)

SPN is initiated on ICU day 8 if enteral nutrition remains \<50% of the target caloric requirement. Nutrition support is guided by the same protocol as in the early SPN group.

Sponsors & Collaborators

  • Dong Zhang

    lead OTHER

Principal Investigators

  • dong zhang · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2027-07-20
Completion
2029-07-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07085455 on ClinicalTrials.gov