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

RecruitingNAAges 18 Years - anyAllDong Zhang
NCT07085455 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 (โ‰ฅ18 years) with at least one organ failure (SOFA score โ‰ฅ2) within 24

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria๏ผš 1. Age โ‰ฅ 18 years 2. Failure of one or more organ systems within 24 hours of ICU admission, defined as Sequential Organ Failure Assessment (SOFA) score โ‰ฅ 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
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What it tests

  • Early Supplemental Parenteral Nutrition (SPN)
  • Late Supplemental Parenteral Nutrition (SPN)
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Where

2 sites
The First Hospital of Jilin University
Changchun, China
The First Hospital of Jilin University
Changchun, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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