MedPath

Resolution of organ injury in acute pancreatitis

Not Applicable
Completed
Conditions
Acute pancreatitis
Digestive System
Registration Number
ISRCTN50581876
Lead Sponsor
The University of Edinburgh
Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33293311/ (added 10/03/2022)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
229
Inclusion Criteria

1. All patients treated at Royal Infirmary Edinburgh with a clinical or radiological diagnosis of acute pancreatitis will be recruited where possible
2. For the potential clinical diagnosis of acute pancreatitis an appropriate clinical history based on compatible clinical features, will be required (i.e. abdominal pain, nausea and/or vomiting), supported by the finding of elevated serum amylase greater than 3x the upper limit of the reference range for the laboratory (currently 300 U/L)
3. For the radiological diagnosis, if applicable, computerised tomography (CT) and/or ultrasound scan (USS) evidence of acute pancreatitis will be accepted
4. With the exception of prisoners, all adult patients with capacity to give informed consent will be considered

Exclusion Criteria

Current exclusion criteria as of 09/04/2024:

1. Patients under the age of 16 years will be excluded from the present study
2. Prisoners will be excluded from the present study
3. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity during the hospital admission

The additional two exclusions below apply only to those patients being considered for the nested cohort study:
4. Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker)
5. Patients with a known allergy to salbutamol

_____

Previous Participant exclusion criteria (as of 18/12/2017):

1. Patients under the age of 16 years will be excluded from the present study
2. Prisoners will be excluded from the present study
3. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity

The additional two exclusions below apply only to those patients being considered for the nested cohort study:
4. Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker)
5. Patients with a known allergy to salbutamol

_____

Previous Participant exclusion criteria:

1. Patients under the age of 16 years will be excluded from the present study
2. Prisoners will be excluded from the present study
3. Patients lacking the capacity to consent will be excluded but can be included if they regain capacity
4. Patients not able to undergo MRI scanning for technical reasons will be excluded (e.g. those with cochlear implants, implanted pacemaker)
5. An additional exclusion will apply only to those patients being considered for the nested cohort study: patients with a known allergy to salbutamol

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The incidence of new onset type 3c diabetes mellitus in patients with AP measured at 27 months, compared to the age matched population of Scotland
Secondary Outcome Measures
NameTimeMethod
Full peripheral venous blood profiling, including cardiac biomarkers, standard biochemistry profiling, and samples retained for miRNA profiling, cytokines, telomere length, metabolomic profiling, proteomic profiling, transcriptomic profiling, genomic profiling, leukocyte subset analysis by flow cytometry, at recruitment, 3 months and 27 months after AP
© Copyright 2025. All Rights Reserved by MedPath