Acute Pancreatitis Drug-InducedNCT07076316
Early Rehabilitation Nursing for Severe Acute Pancreatitis
A study testing Structured Early Rehabilitation Nursing Pathway and Routine Care in people with Acute Pancreatitis Drug-Induced, run by Qiandi Huang at 1 site in China.
Trial summary
This randomized controlled trial evaluates the clinical efficacy of a structured early rehabilitation nursing (ERN) pathway compared to routine care in patients with severe acute pancreatitis (SAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis Drug-Induced
- What is being tested?
- Structured Early Rehabilitation Nursing Pathway and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Severe Acute Pancreatitis (SAP) according to the Revised Atlanta Classification.
- APACHE II score > 8.
- Expected ICU stay ≥ 14 days.
- Hemodynamic stability (mean arterial pressure ≥ 65 mmHg for > 24 hours).
- Provided informed consent.
Who cannot join
- Presence of chronic metabolic disorders (e.g., end-stage renal disease, cirrhosis).
- Coagulopathy (INR > 1.5 or platelet count < 50×10⁹/L).
- Cognitive impairment hindering cooperation with the rehabilitation protocol.
- Recent use of antiplatelet or anticoagulant medication (within 7 days).
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Jianghan University, The Sixth Hospital of Wuhan
Wuhan, Hubei, 430000
About this study
Official title: Effects of a Structured Early Rehabilitation Nursing Pathway on Gastrointestinal Recovery and Quality of Life in Severe Acute Pancreatitis Patients: A Randomized Controlled Trial
This randomized controlled trial evaluates the clinical efficacy of a structured early rehabilitation nursing (ERN) pathway compared to routine care in patients with severe acute pancreatitis (SAP). The study aims to determine if the ERN pathway, which includes phased mobility, respiratory training, and psychological support, can improve gastrointestinal recovery, reduce hospital stay and complications, and enhance functional independence and quality of life.
Read the detailed description
Severe acute pancreatitis (SAP) is a life-threatening condition with high mortality and morbidity, often complicated by prolonged immobilization, leading to muscle atrophy, delayed gut recovery, and increased infection risk. Current nursing practices often neglect early mobilization. This study introduced and tested a structured early rehabilitation nursing pathway (SERNP) designed to address these gaps. A total of 104 eligible SAP patients were randomly assigned to either the SERNP group (n=52) or a control group receiving routine care (n=52). The SERNP intervention was initiated within 48 hours of achieving hemodynamic stability and was delivered in three phases over 14 days: Phase 1 (Days 1-3) focused on bedside passive exercises and respiratory training; Phase 2 (Days 4-7) introduced progressive mobilization like sitting and assisted standing; and Phase 3 (Days 8-14) involved supervised ambulation. The study hypothesis was that the SERNP would accelerate recovery and improve outcomes by addressing both the physiological and psychosocial consequences of SAP.
- Conditions
- Acute Pancreatitis Drug-Induced
- Being tested
- Structured Early Rehabilitation Nursing Pathway, Routine Care
- Keywords
- Early Rehabilitation Nursing, Severe Acute Pancreatitis, Patient-Centered Care, Functional Recovery, Critical Care, Quality of Life
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Early Rehabilitation Nursing PathwayBehavioural
A multi-component, phased nursing intervention focused on early and progressive mobilization, respiratory exercises, and psychological support.
Routine CareBehavioural
Standard nursing care for severe acute pancreatitis patients in the ICU, including monitoring and passive limb mobilization.
| Study group | Role | What they receive |
|---|---|---|
| ERN Group | Experimental | Patients received a structured early rehabilitation nursing pathway (SERNP) in addition to routine care. The intervention was implemented within 48 hours of hemodynamic stability and included:
* Phase 1 (Days 1-3): Bedside passive range-of-motion exercises (10 min/session, 2x/day), respiratory training (lip pursing and abdominal breathing, 3 sessions/day), and gradual head-of-bed elevation (30° to 90°).
* Phase 2 (Days 4-7): Progressive mobilization including sitting at bedside (5-10 min, 3x/day) and assisted standing with a tilt-table (≤15 min/session).
* Phase 3 (Days 8-14): Supervised ambulation (2-5 meters, 2x/day) with mobility aids. Receives: Behavioral: Structured Early Rehabilitation Nursing Pathway |
| Control Group | Active comparator | Patients received routine care, which included vital sign monitoring, strict fasting, fluid balance recording, and passive limb mobilization twice daily. Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Relief of Abdominal Distension
Time in days from randomization until the resolution of abdominal distension, as assessed by clinical evaluation.
Measured: From randomization up to hospital discharge (an average of 14 days)
Time to First Bowel Movement
Time in days from randomization until the first anal exhaust (bowel movement).
Measured: From randomization up to hospital discharge (an average of 14 days)
Duration of Hospital Stay
Total length of stay in the hospital, measured in days.
Measured: From hospital admission up to hospital discharge (an average of 14 days)
Incidence of Complications
Percentage of patients who developed complications, including pressure ulcers, pneumonia, and venous thrombosis.
Measured: From randomization until hospital discharge (an average of 14 days)
Secondary outcomes (3)
Activities of Daily Living (ADL) Score
Functional independence measured using the Barthel Index (BI). The scale ranges from 0 to 100, with higher scores indicating greater independence.
Measured: Within 24 hours prior to Intensive Care Unit (ICU) discharge
Quality of Life (QoL) Score
Quality of life assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. This measures four domains: physical health, psychological health, social relationships, and environment. Scores are transformed to a 0-100 scale, with higher scores indicating better QoL.
Measured: At 48 hours prior to hospital discharge
Nursing Satisfaction
Patient satisfaction with nursing care, measured using a 10-item Likert scale developed for ICU settings. The rate of patients rating care as "satisfied" or "very satisfied" was calculated.
Measured: Within 24 hours prior to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Feb 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pancreatitis Drug-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qiandi Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiandi Huang, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076316
- Sponsor's protocol ID
- JHUSH-SAP-ERN-2021-01
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Structured Early Rehabilitation Nursing Pathway on Gastrointestinal Recovery and Quality of Life in Severe Acute Pancreatitis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07076316
- Acronym / sponsor ID
- JHUSH-SAP-ERN-2021-01
- Conditions
- Acute Pancreatitis Drug-Induced
- Keywords
- Early Rehabilitation Nursing, Severe Acute Pancreatitis, Patient-Centered Care, Functional Recovery, Critical Care, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Qiandi HuangUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluates the clinical efficacy of a structured early rehabilitation nursing (ERN) pathway compared to routine care in patients with severe acute pancreatitis (SAP). The study aims to determine if the ERN pathway, which includes phased mobility, respiratory training, and psychological support, can improve gastrointestinal recovery, reduce hospital stay and complications, and enhance functional independence and quality of life.
Detailed description
Severe acute pancreatitis (SAP) is a life-threatening condition with high mortality and morbidity, often complicated by prolonged immobilization, leading to muscle atrophy, delayed gut recovery, and increased infection risk. Current nursing practices often neglect early mobilization. This study introduced and tested a structured early rehabilitation nursing pathway (SERNP) designed to address these gaps. A total of 104 eligible SAP patients were randomly assigned to either the SERNP group (n=52) or a control group receiving routine care (n=52). The SERNP intervention was initiated within 48 hours of achieving hemodynamic stability and was delivered in three phases over 14 days: Phase 1 (Days 1-3) focused on bedside passive exercises and respiratory training; Phase 2 (Days 4-7) introduced progressive mobilization like sitting and assisted standing; and Phase 3 (Days 8-14) involved supervised ambulation. The study hypothesis was that the SERNP would accelerate recovery and improve outcomes by addressing both the physiological and psychosocial consequences of SAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERN Group | Experimental | Behavioral: Structured Early Rehabilitation Nursing PathwayPatients received a structured early rehabilitation nursing pathway (SERNP) in addition to routine care. The intervention was implemented within 48 hours of hemodynamic stability and included: * Phase 1 (Days 1-3): Bedside passive range-of-motion exercises (10 min/session, 2x/day), respiratory training (lip pursing and abdominal breathing, 3 sessions/day), and gradual head-of-bed elevation (30° to 90°). * Phase 2 (Days 4-7): Progressive mobilization including sitting at bedside (5-10 min, 3x/day) and assisted standing with a tilt-table (≤15 min/session). * Phase 3 (Days 8-14): Supervised ambulation (2-5 meters, 2x/day) with mobility aids. |
| Control Group | Active comparator | Behavioral: Routine CarePatients received routine care, which included vital sign monitoring, strict fasting, fluid balance recording, and passive limb mobilization twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Severe Acute Pancreatitis (SAP) according to the Revised Atlanta Classification.
- APACHE II score > 8.
- Expected ICU stay ≥ 14 days.
- Hemodynamic stability (mean arterial pressure ≥ 65 mmHg for > 24 hours).
- Provided informed consent.
Key exclusion criteria (4 listed)
- Presence of chronic metabolic disorders (e.g., end-stage renal disease, cirrhosis).
- Coagulopathy (INR > 1.5 or platelet count < 50×10⁹/L).
- Cognitive impairment hindering cooperation with the rehabilitation protocol.
- Recent use of antiplatelet or anticoagulant medication (within 7 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Early Rehabilitation Nursing PathwayA multi-component, phased nursing intervention focused on early and progressive mobilization, respiratory exercises, and psychological support. | Behavioural | ERN Group |
| Routine CareStandard nursing care for severe acute pancreatitis patients in the ICU, including monitoring and passive limb mobilization. | Behavioural | Control Group |
Primary outcome
Time to Relief of Abdominal Distension
Time frame: From randomization up to hospital discharge (an average of 14 days)
Time in days from randomization until the resolution of abdominal distension, as assessed by clinical evaluation.
Time to First Bowel Movement
Time frame: From randomization up to hospital discharge (an average of 14 days)
Time in days from randomization until the first anal exhaust (bowel movement).
Duration of Hospital Stay
Time frame: From hospital admission up to hospital discharge (an average of 14 days)
Total length of stay in the hospital, measured in days.
Incidence of Complications
Time frame: From randomization until hospital discharge (an average of 14 days)
Percentage of patients who developed complications, including pressure ulcers, pneumonia, and venous thrombosis.
3 secondary outcomes
Activities of Daily Living (ADL) Score
Time frame: Within 24 hours prior to Intensive Care Unit (ICU) discharge
Quality of Life (QoL) Score
Time frame: At 48 hours prior to hospital discharge
Nursing Satisfaction
Time frame: Within 24 hours prior to hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
Related trials for Acute Pancreatitis Drug-Induced
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Early Rehabilitation Nursing Pathway and Routine Care in people with Acute Pancreatitis Drug-Induced, run by Qiandi Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Relief of Abdominal Distension (time frame: From randomization up to hospital discharge (an average of 14 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.