The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN): A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 946
- 试验地点
- 2
- 主要终点
- 28-Day All-Cause Mortality
研究概览
简要总结
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.
详细描述
This is a multicenter, randomized, controlled clinical trial designed to evaluate the impact of early supplemental parenteral nutrition (SPN) versus late SPN initiation on clinical outcomes in critically ill patients. The primary objective is to determine whether initiating SPN on day 4 of ICU admission, compared to day 8, can reduce 28-day all-cause mortality. Secondary objectives include assessing the effects of early SPN on functional status (2-year EQ-5D-5L), mortality at various time points (ICU, 28-day, 90-day, 180-day, and 2-year), ICU length of stay, nutritional markers (prealbumin levels on days 8 and 28), muscle mass indicators (diaphragm thickness, biceps, quadriceps, and rectus femoris cross-sectional area), incidence of ICU-acquired infections, ventilator-free days, and metabolic adverse events (such as hyperglycemia, hypoglycemia, hyperlipidemia, and liver dysfunction).
Baseline and clinical process data will be collected for all enrolled patients within the first 24 hours of ICU admission. This includes demographic data (age, sex, height, weight), severity scores (APACHE II, SOFA), and nutritional status.
Additional ICU-related data will be recorded, including:
Use of sedation and analgesia (yes/no), and Richmond Agitation-Sedation Scale (RASS) scores Use of vasopressors (yes/no), type of agent(s), dosage, and duration Vital signs, fluid balance, and mechanical ventilation status Contact information for patient surrogates or family members will be obtained to facilitate follow-up at Day 28, Day 90, Day 180, and 2 years after ICU admission.
Randomization Method A free recruitment model was adopted nationwide. The randomization plan was developed by the study statistician. Dynamic block randomization stratified by participating centers was used to allocate participants to either the early or late SPN group in a 1:1 ratio. The size of the permutation blocks was variable and blinded to the treating clinicians and nursing staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Enteral nutrition providing <50% of target caloric requirements within 72 hour
排除标准
- •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
研究组 & 干预措施
Early SPN Group
Patients in this group will receive supplemental parenteral nutrition (SPN) starting on day 4 after ICU admission, in addition to standard enteral nutrition (EN).
干预措施: Early Supplemental Parenteral Nutrition (SPN) (Dietary Supplement)
Late SPN Group
Patients in this group will receive SPN starting on day 8 after ICU admission, in addition to standard EN.
干预措施: Late Supplemental Parenteral Nutrition (SPN) (Dietary Supplement)
结局指标
主要结局
28-Day All-Cause Mortality
时间窗: 28 days after ICU admission
Death from any cause occurring within 28 days of ICU admission. This is a binary outcome (alive or dead). Lower mortality indicates better outcome.
次要结局
- 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)
- Ventilator-Free Days Within 28 Days After ICU Admission(28 days after ICU admission)
- All-Cause Mortality at Multiple Time Points (ICU, 28days，90 days, 180 days, 2 years)(From ICU admission to 2 years after ICU admission)
- The number of participants with Laboratory Safety Parameters and Liver Dysfunction(From ICU admission to Day 28)
研究者
Dong Zhang
chief physician
The First Hospital of Jilin University