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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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