Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis (COPA)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Copeptin Pancreatitis Trial|
- Association between copeptin level and severity of pancreatitis (according to Atlanta classification) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]Copeptin level will be measured on admission into hospital and severity of pancreatitis will be classified according to the Atlanta criteria.
- Comparison of copeptin with C reactive protein and procalcitonin in terms of assessing severity of pancreatitis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Predictive accuracy of copeptin, CRP and procalcitonin in terms of developing organ failure, necrosis and/or superinfection and mortality [ Time Frame: Duration of hospitalisation ] [ Designated as safety issue: No ]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 [ Time Frame: Duration of hospitalisation ] [ Designated as safety issue: No ]To determine if the change in copeptin level is associated with organ failure, necrosis and superinfection
Biospecimen Retention: Samples With DNA
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293318
|Contact: Christian A Nebiker, MD, Dr.||firstname.lastname@example.org|
|Contact: Rachel Rosenthal, MD, Prof.||email@example.com|
|University Hospital Basel||Recruiting|
|Basel, Switzerland, 4031|
|Principal Investigator: Christian A Nebiker, MD, Dr.|
|Principal Investigator:||Christian A Nebiker, MD, Dr.||University Hospital, Basel, Switzerland|