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

NCT07085455 | Recruiting

• 1 other identifier: T-SPN
• Study Type: interventional
• Target: 946
• Locations: 1 country
• Sites: 2

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.

Conditions

Critical Illness; Organ Dysfunction; Enteral Nutrition Intolerance; Inadequate Nutritional Intake

Keywords

Nutritional support; Supplementary parenteral nutrition; Early enteral nutrition; Severe patients; critical care; intensive care

Outcome Measures

Primary Outcomes (1)

• 28-Day All-Cause Mortality

  Death from any cause occurring within 28 days of ICU admission. This is a binary outcome (alive or dead). Lower mortality indicates better outcome.

  28 days after ICU admission

Secondary Outcomes (8)

• physical function score： EuroQol 5-Dimension 5-Level Questionnaire（EQ5D5L）

  28 days after ICU admission，90 days after ICU admission，180 days after ICU admission，2 years after ICU admission

• ICU Length of Stay

  Duration of ICU stay, from admission to discharge from ICU up to 28 days

• Serum Prealbumin Levels on Day 8, Day 28, Day 90, Day 180, and 2 Years

  ICU day 8, day 28, and at 90 days, 180 days, and 2 years after ICU admission

• Muscle Ultrasound Measurements on Day 8, Day 28, Day 90, Day 180, and 2 Years

  ICU day 8, day 28, and at 90 days, 180 days, and 2 years after ICU admission

• Incidence of New Infections in the ICU

  From ICU admission to ICU discharge up to 28 days

Other Outcomes (1)

• Gastrointestinal Tolerance and Intestinal Function Indicators

  Day 8 and Day 28 after ICU admission

Study Arms (2)

Early SPN Group

EXPERIMENTAL

Patients in this group will receive supplemental parenteral nutrition (SPN) starting on day 4 after ICU admission, in addition to standard enteral nutrition (EN).

Dietary Supplement: Early Supplemental Parenteral Nutrition (SPN)

Late SPN Group

ACTIVE COMPARATOR

Patients in this group will receive SPN starting on day 8 after ICU admission, in addition to standard EN.

Dietary Supplement: Late Supplemental Parenteral Nutrition (SPN)

Interventions

Early Supplemental Parenteral Nutrition (SPN) DIETARY_SUPPLEMENT

SPN is initiated on ICU day 4 if enteral nutrition remains \<50% of the target caloric requirement. Nutrition support is guided by protocol

Early SPN Group

Late Supplemental Parenteral Nutrition (SPN) DIETARY_SUPPLEMENT

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.

Late SPN Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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
• Expected ICU stay \> 72 hours
• Able to initiate early enteral nutrition (EN) within 48 hours of ICU admission

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong Zhang: lead

Study Sites (2)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• dong zhang

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

yanhua li

CONTACT

86-15804301738; liyanhua@jiu.edu.cn

youquan wang

CONTACT

86-15584299391; wangyq20@mails.jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to group assignment to reduce expectation bias. The clinical staff administering the nutrition intervention are not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Model Details: Participants are randomized in a 1:1 ratio to either the early supplemental parenteral nutrition (SPN) group or the late SPN group. Each group receives only one intervention throughout the study period, and outcomes are compared in a parallel manner.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 25, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2029
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)