Timing of supplemental parenteral nutrition in critically ill adults
The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN): A Multicenter Randomized Controlled Trial
This trial will test whether starting supplemental parenteral (intravenous) nutrition on day 4 versus day 8 after ICU admission reduces 28-day death in critically ill adults who cannot meet calorie needs with enteral feeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 946 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Changchun, Jilin and 1 other locations) |
| Trial ID | NCT07085455 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with at least one organ failure (SOFA ≥2) within 24 hours of ICU admission, expected to remain in the ICU >72 hours, able to start enteral nutrition within 48 hours but receiving <50% of target calories within 72 hours are eligible.
Not a fit: Patients who can tolerate full oral or full-dose enteral nutrition, those expected to die within 72 hours, pregnant or lactating women, or those with contraindications to parenteral nutrition are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, earlier supplemental parenteral nutrition could reduce short-term mortality and help preserve muscle and long-term functional outcomes by preventing prolonged energy deficits.
How similar studies have performed: Previous randomized trials of early versus delayed supplemental parenteral nutrition have produced mixed results—some showing no mortality benefit or increased complications—so the specific day-4 versus day-8 timing with detailed long-term functional and muscle endpoints is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Changchun, Jilin and 1 other locations
- The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: yanhua li
- Email: liyanhua@jiu.edu.cn
- Phone: 86-15804301738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.