Early Rehabilitation for Severe Acute Pancreatitis (ERN-SAP)

NCT ID: NCT07109921

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2025-06-01

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.

Conditions

Severe Acute Pancreatitis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Early Rehabilitation Nursing (ERN) Group

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.

Group Type: EXPERIMENTAL

Structured Early Rehabilitation Nursing Program

Intervention Type: BEHAVIORAL

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.

Active Comparator: Usual Care Group

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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.

Interventions

Structured 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.

Intervention Type: BEHAVIORAL

Usual 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

OTHER

Sponsor Role: lead

Responsible Party

Qiandi Huang

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

Wuhan, Hubei, China

Countries

China

Other Identifiers

WHSHIRB-K-2019015

Identifier Type: -

Identifier Source: org_study_id