Severe Acute Pancreatitis Patients
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStructured Early Rehabilitation Nursing Program
A protocolized, phased program. Phase 1 (unconscious): passive range of motion and repositioning. Phase 2 (awake/stable): respiratory training (deep breathing, incentive spirometry), bed mobility (bridging, rolling), and progressive mobilization (sitting at edge of bed). Phase 3 (active): in-place stepping and supervised ambulation. Psychological support was provided throughout. Safety criteria were monitored continuously.
OTHERUsual Care
Standard ICU management for SAP as directed by the primary ICU team. Rehabilitation was discretionary, typically limited to passive range of motion exercises by bedside nurses if deemed necessary.
Sponsors
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 75 years. 2. A diagnosis of SAP according to the 2012 revised Atlanta classification. 3. Admission to the ICU within 72 hours of symptom onset. 4. An anticipated ICU stay of more than 48 hours.
Exclusion criteria
1. Pre-existing conditions precluding rehabilitation (e.g., severe neuromuscular disease, unstable spinal fractures). 2. Acute myocardial infarction or unstable cardiac arrhythmia. 3. Intracranial hypertension. 4. Active gastrointestinal bleeding. 5. Pregnancy. 6. Patient or family refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay (LOS) | 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) | From hospital admission to hospital discharge (assessed up to 90 days) | Defined as the total time from hospital admission to discharge, measured in days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | At ICU discharge (within 24 hours prior to transfer from ICU) | Assessed using the Medical Research Council (MRC) sum score, which ranges from 0 (complete paralysis) to 60 (normal strength). A score \<48 indicates ICU-acquired weakness. |
| Change in Functional Independence | Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge | Assessed using the Barthel Index for Activities of Daily Living (ADL). The score ranges from 0 to 100, where higher scores indicate greater independence. |
| Change in Quality of Life | Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge | Measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) instrument, which assesses physical health, psychological health, social relationships, and environment domains. Domain scores are transformed to a 0-100 scale, where higher scores indicate better quality of life. |
| Change in C-reactive protein (CRP) level | Baseline, Day 7 | Serum levels of CRP, measured in mg/L, to assess systemic inflammation. |
| Incidence of ICU-Acquired Complications | During ICU stay | Number of patients experiencing pre-specified complications, including pressure ulcers, ventilator-associated pneumonia, and deep vein thrombosis. |
| Patient and/or Family Satisfaction | At hospital discharge (within 24 hours prior to discharge) | Assessed using a validated 5-point Likert scale at discharge. The scale measures satisfaction with nursing care, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction. |
| One-Year All-Cause Mortality | Up to 12 months | Number of deaths from any cause within 12 months of randomization. |
| Change in Interleukin-6 (IL-6) level | Baseline, Day 7 | Serum levels of IL-6, measured in pg/mL, to assess systemic inflammation. |
Countries
China
Outcome results
None listed