A randomised controlled trial of a procalcitonin-based algorithm to guide antibiotic use in acute pancreatitis

Not Applicable

Completed

• Conditions: Acute pancreatitis; Digestive System

• Registration Number: ISRCTN50584992
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31358032 protocol (added 31/07/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35863358/ (added 22/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-07
• Study Completion: 2020-12-31
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 260

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 25/03/2020:<br> 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.<br> Antibiotics prescribed before the index admission (from the referring hospital or community) will be recorded at admission but not included in the primary endpoint.<br><br><br> Previous primary outcome measure:<br> 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).<br>