Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis

Completed

• Conditions: Acute Pancreatitis; Pancreatitis
• Interventions: Other: No intervention

• Registration Number: NCT01293318
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The purpose of this study is to investigate if there is an association between copeptin level in serum and the severity of pancreatitis and if copeptin can be used as a predictor for organ failure and pancreatic necrosis with or without superinfection.

Detailed Description

Acute pancreatitis may range from mild to severe disease with high mortality in case of infected pancreatic necrosis. Due to its rising incidence it remains an important healthcare problem in Europe and US. The assessment of the severity of pancreatitis is crucial for the further management and the prognosis. Several quite complex scores like Ranson or APACHE II scores has been used in the past with reasonable sensitivity for necrosis or superinfection as well as inflammation markers like c-reactive Protein.

Copeptin, the C-terminal part of antidiuretic hormone, is a relatively stable peptide in blood circulation. Several studies investigated Copeptin in the presence of Systemic Inflammatory Response Syndrome (SIRS) or sepsis, myocardial infarction, lower respiratory tract infection and cerebral stroke. Copeptin has shown to be a helpful prognostic marker in these diseases. The aim of this prospective study is to investigate whether Copeptin can be used to assess the severity of pancreatitis.

Study Timeline

• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Study Start: 2011-03
• Primary Completion: 2015-11
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• diagnosis of acute pancreatitis
• written informed consent
• inpatient treatment

Exclusion Criteria

• time interval between onset of abdominal symptoms and study inclusion >96h
• patients unable to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute pancreatitis	No intervention	-

Primary Outcome Measures

Name	Time	Method
Association between copeptin level and severity of pancreatitis (according to Atlanta classification)	48 hours	Copeptin level will be measured on admission into hospital and severity of pancreatitis will be classified according to the Atlanta criteria.

Secondary Outcome Measures

Name	Time	Method
Comparison of copeptin with C reactive protein and procalcitonin in terms of assessing severity of pancreatitis	48 hours
Predictive accuracy of copeptin, C reactive Protein (CRP) and procalcitonin in terms of developing organ failure, necrosis and/or superinfection and mortality	Duration of hospitalisation	Determinating Atlanta score, Sofa score. Assessing local complications by checking CT scan and searching for superinfection in fine needle aspiration and/or biopsy.
Determine whether change in copeptin level from day 0 to 2 is associated with organ failure, necrosis and/or superinfection	Duration of hospitalisation	To determine if the change in copeptin level is associated with organ failure, necrosis and superinfection

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland