Acute pancreatitis Digestive System Acute pancreatitis
Conditions
Interventions
Method of randomisation:
Web-based randomisation will be provided by the Clinical Trials Unit of the University of Edinburgh (https://www.ed.ac.uk/usher/edinburgh-clinical-trials). Al
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients presenting with acute pancreatitis admitted or referred to the service. Inclusion criteria include: 1. Patients over the age of 18 years of age 2. Ability to provide informed consent 3. The diagnosis of acute pancreatitis requires two of the following three features: 3.1. Abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back) 3.2. Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal 3.3. Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT) and less commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography
Exclusion criteria
Exclusion criteria: 1. Patients under the age of 18 years of age 2. Patients who are unable to give informed consent (criterion removed 14/06/2019) 3. Infectious conditions requiring prolonged antibiotic therapy – such as infective endocarditis 4. Severely immunocompromised patients – such as those with human immunodeficiency virus and with a CD4 count of less than 200 cells/mm3; neutropenic patients (<500 neutrophils/mm3) 5. Patients on immunosuppressive therapy 6. Previous thyroid surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/03/2020: Whether antibiotic use is initiated during the index stay. Trial antibiotic use will exclude mandated routine antibiotic use, specifically prophylaxis before procedures such as laparoscopic cholecystectomy or ERCP. Antibiotics prescribed before the index admission (from the referring hospital or community) will be recorded at admission but not included in the primary endpoint. Previous primary outcome measure: Days of antibiotic use, defined as any day (24 hour period) when antibiotics were prescribed on the patient’s drug prescription chart and administered. This will be recorded as days of antibiotic use until the 90th day or until discharge from hospital (if later). | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcomes measured as occurring up to the 90th day or until discharge from hospital (if later): 1. Clinical infections as defined according to the centers for disease control 2. New isolates of multi-resistant bacteria (Clostridium difficle, vancomycin resistant enterococcus [VRE], methicillin resistant staphylococcus aureus [MRSA], carbapenemase producing enterobacteriaceae [CPE]) 3. Incidence of multi-resistant organism bacteraemia 4. Infection of pancreatic necrosis, defined either as a result of fine needle aspiration (FNA), radiological evidence of gas in a peri-pancreatic collection or positive microbiological cultures from surgical or post-mortem specimens 5. Use of radiological, endoscopic or surgical intervention 6. Length of inpatient stay (by level of care: critical care levels II/III, ward-based care) 7. Re-admission to hospital within 6 weeks of onset of index episode 8. Episode-related mortality and cause 9. Quality of life, assessed by the EQ-5D-5L questionnaire 10. Cost analysis from an NHS perspective, including inpatient resource use | — |
Countries
England, United Kingdom
Outcome results
None listed