NCT07085455 The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN)
| NCT ID | NCT07085455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dong Zhang |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 946 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2027-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 946 participants in total. It began in 2025-09-09 with a primary completion date of 2027-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
dong zhang
STUDY DIRECTOR
The First Hospital of Jilin University
Frequently Asked Questions
Who can join the NCT07085455 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07085455 currently recruiting?
Yes, NCT07085455 is actively recruiting participants. Contact the research team at liyanhua@jiu.edu.cn for enrollment information.
Where is the NCT07085455 trial being conducted?
This trial is being conducted at Changchun, China, Changchun, China.
Who is sponsoring the NCT07085455 clinical trial?
NCT07085455 is sponsored by Dong Zhang. The principal investigator is dong zhang at The First Hospital of Jilin University. The trial plans to enroll 946 participants.