Effect of a Structured Early Rehabilitation Program on Long-Term Functional Recovery, Quality of Life, and Survival in Patients With Severe Acute Pancreatitis: A 5-Year Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- ICU Length of Stay (LOS)
研究概览
简要总结
This prospective, randomized controlled trial investigates the efficacy of a structured early rehabilitation nursing (ERN) program compared to usual care in patients with severe acute pancreatitis (SAP). Four hundred patients admitted to the intensive care unit (ICU) were randomized to either receive the ERN intervention or usual care. The study aims to evaluate the effects of ERN on ICU and hospital length of stay, systemic inflammation, physical function, long-term quality of life, and one-year survival.
详细描述
Patients with severe acute pancreatitis (SAP) often experience prolonged immobilization in the ICU, leading to complications such as ICU-acquired weakness (ICU-AW), extended hospital stays, and poor long-term functional outcomes. While early rehabilitation is beneficial in general critical care, its application in SAP is not well-established. This study was designed to address this gap by evaluating a comprehensive, structured early rehabilitation nursing (ERN) program. The program includes progressive mobilization, respiratory therapy, and psychological support, initiated within 48 hours of ICU admission. The hypothesis is that the ERN program, compared to usual care, will attenuate systemic inflammation, accelerate physical recovery, reduce length of stay, and lead to superior long-term functional independence, quality of life, and 1-year survival in patients with SAP.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years.
- •A diagnosis of SAP according to the 2012 revised Atlanta classification.
- •Admission to the ICU within 72 hours of symptom onset.
- •An anticipated ICU stay of more than 48 hours.
排除标准
- •Pre-existing conditions precluding rehabilitation (e.g., severe neuromuscular disease, unstable spinal fractures).
- •Acute myocardial infarction or unstable cardiac arrhythmia.
- •Intracranial hypertension.
- •Active gastrointestinal bleeding.
- •Patient or family refusal.
结局指标
主要结局
ICU Length of Stay (LOS)
时间窗: From ICU admission to ICU discharge (assessed up to 90 days)
Defined as the time from ICU admission to discharge, measured in days.
Hospital Length of Stay (LOS)
时间窗: From hospital admission to hospital discharge (assessed up to 90 days)
Defined as the total time from hospital admission to discharge, measured in days.
次要结局
- Change in C-reactive protein (CRP) level(Baseline, Day 7)
- Change in Interleukin-6 (IL-6) level(Baseline, Day 7)
- Muscle Strength(At ICU discharge (within 24 hours prior to transfer from ICU))
- Change in Functional Independence(Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge)
- Change in Quality of Life(Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge)
- One-Year All-Cause Mortality(Up to 12 months)
- Incidence of ICU-Acquired Complications(During ICU stay)
- Patient and/or Family Satisfaction(At hospital discharge (within 24 hours prior to discharge))
研究者
Qiandi Huang
Principal investigator
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University