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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

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.

Eligibility

Primary outcome measure(s)

• 28-Day All-Cause Mortality — 28 days after ICU admission
  Death from any cause occurring within 28 days of ICU admission. This is a binary outcome (alive or dead). Lower mortality indicates better outcome.

Trial sites (2)

Other trials for the same condition