Timing of supplemental parenteral nutrition in critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial will assign critically ill adult ICU patients who are unable to reach 50% of their caloric needs by enteral nutrition to receive supplemental parenteral nutrition (SPN) beginning on day 4 versus day 8 after ICU admission. The primary outcome is 28-day all-cause mortality, with secondary outcomes including mortality at multiple time points through two years, 2-year EQ-5D-5L functional status, ICU length of stay, nutritional markers (prealbumin), muscle mass measurements, ICU-acquired infections, ventilator-free days, and metabolic adverse events. Baseline demographic, severity (APACHE II, SOFA) and nutritional data are collected within 24 hours of ICU admission and relevant clinical data are recorded throughout the ICU stay. The trial is conducted at participating ICUs with standardized protocols for enteral feeding, SPN administration, and outcome measurement.

Why it matters

Who can join: the full rules

Inclusion Criteria：

1. Age ≥ 18 years
2. 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
3. Expected ICU stay \> 72 hours
4. Able to initiate early enteral nutrition (EN) within 48 hours of ICU admission
5. Enteral nutrition providing \<50% of target caloric requirements within 72 hour Exclusion Criteria

1.Full oral intake or tolerance of full-dose EN; no need for SPN 2.Receiving palliative care or expected to die within 72 hours 3.Pregnant or lactating women 4.Long-term use of systemic corticosteroids or other immunosuppressive agents 5.Known malignancy currently receiving radiotherapy or chemotherapy 6.Contraindications to parenteral nutrition (PN) 7.Participation in another interventional clinical trial

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• The First Hospital of Jilin University
  Changchun, Jilin, China Not yet recruiting

Study contacts

• Study coordinator: yanhua li
• Email: liyanhua@jiu.edu.cn
• Phone: 86-15804301738

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.