Early Rehabilitation for Severe Acute Pancreatitis (ERN-SAP)

NCT07109921 | Completed

• 1 other identifier: WHSHIRB-K-2019015
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Pancreatitis Patients

Outcome Measures

Primary Outcomes (2)

• ICU Length of Stay (LOS)

  Defined as the time from ICU admission to discharge, measured in days.

  From ICU admission to ICU discharge (assessed up to 90 days)

• Hospital Length of Stay (LOS)

  Defined as the total time from hospital admission to discharge, measured in days.

  From hospital admission to hospital discharge (assessed up to 90 days)

Secondary Outcomes (8)

• 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

Study Arms (2)

Experimental: Early Rehabilitation Nursing (ERN) Group

EXPERIMENTAL

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.

Behavioral: Structured Early Rehabilitation Nursing Program

Active Comparator: Usual Care Group

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Structured Early Rehabilitation Nursing Program 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.

Experimental: Early Rehabilitation Nursing (ERN) Group

Usual Care 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.

Active Comparator: Usual Care Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy.
• Patient or family refusal.

Sponsors & Collaborators

• Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University: lead

Study Sites (1)

The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

Wuhan, Hubei, 430000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 7, 2025
• Study Start: June 1, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

CN (1)