CompletedNot Applicable

Early Rehabilitation for Severe Acute Pancreatitis (ERN-SAP)

China400 participantsStarted 2019-06-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

ICU Length of Stay (LOS)

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

Hospital Length of Stay (LOS)

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

Trial details

NCT IDNCT07109921

SponsorSixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Severe Acute Pancreatitis Patients trials