Early Rehabilitation for Severe Acute Pancreatitis (ERN-SAP)

Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

Status: Completed

Conditions: Severe Acute Pancreatitis Patients

Treatments: Other: Usual Care; Behavioral: Structured Early Rehabilitation Nursing Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07109921

WHSHIRB-K-2019015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Experimental: Early Rehabilitation Nursing (ERN) Group

Experimental group

Description:

In addition to usual care, patients received a protocolized, multidisciplinary rehabilitation program initiated within 48 hours of ICU admission. The program consisted of progressive, goal-directed mobilization, respiratory therapy, and psychological support, delivered 7 days a week by trained nurses and physical therapists.

Treatment:

Behavioral: Structured Early Rehabilitation Nursing Program

Active Comparator: Usual Care Group

Active Comparator group

Description:

Patients received standard ICU care for SAP, including hemodynamic monitoring, mechanical ventilation, fluid management, nutritional support, and pain control. Rehabilitation was not protocolized and was provided only at the discretion of the treating physician.

Treatment:

Other: Usual Care