This trial is active, not recruiting.

Conditions acute pancreatitis, pancreatitis
Treatment no intervention
Sponsor University Hospital, Basel, Switzerland
Start date March 2011
End date November 2015
Trial size 150 participants
Trial identifier NCT01293318, 281/10


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
no intervention
No intervention

Primary Outcomes

Association between copeptin level and severity of pancreatitis (according to Atlanta classification)
time frame: 48 hours

Secondary Outcomes

Comparison of copeptin with C reactive protein and procalcitonin in terms of assessing severity of pancreatitis
time frame: 48 hours
Predictive accuracy of copeptin, C reactive Protein (CRP) and procalcitonin in terms of developing organ failure, necrosis and/or superinfection and mortality
time frame: Duration of hospitalisation
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Copeptin Pancreatitis Trial
Principal investigator Christian A Nebiker, MD, Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.