Clinical trial NCT01293318: Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis
Official title: Copeptin Pancreatitis Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Pancreatitis
Keywords: Copeptin
Vasopressin
antidiuretic hormone (ADH)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency departement or in-hospital patients with acute pancreatitis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between copeptin level and severity of pancreatitis (according to Atlanta classification)
timeFrame: 48 hours
Secondary outcomes:
measure: Comparison of copeptin with C reactive protein and procalcitonin in terms of assessing severity of pancreatitis
timeFrame: 48 hours
measure: Predictive accuracy of copeptin, C reactive Protein (CRP) and procalcitonin in terms of developing organ failure, necrosis and/or superinfection and mortality
timeFrame: Duration of hospitalisation
measure: Determine whether change in copeptin level from day 0 to 2 is associated with organ failure, necrosis and/or superinfection
timeFrame: Duration of hospitalisation
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christian A Nebiker, MD, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgenthaler NG, Muller B, Struck J, Bergmann A, Redl H, Christ-Crain M. Copeptin, a stable peptide of the arginine vasopressin precursor, is elevated in hemorrhagic and septic shock. Shock. 2007 Aug;28(2):219-26. doi: 10.1097/SHK.0b013e318033e5da.
citation: Muller B, Morgenthaler N, Stolz D, Schuetz P, Muller C, Bingisser R, Bergmann A, Tamm M, Christ-Crain M. Circulating levels of copeptin, a novel biomarker, in lower respiratory tract infections. Eur J Clin Invest. 2007 Feb;37(2):145-52. doi: 10.1111/j.1365-2362.2007.01762.x.
citation: Stolz D, Christ-Crain M, Morgenthaler NG, Leuppi J, Miedinger D, Bingisser R, Muller C, Struck J, Muller B, Tamm M. Copeptin, C-reactive protein, and procalcitonin as prognostic biomarkers in acute exacerbation of COPD. Chest. 2007 Apr;131(4):1058-67. doi: 10.1378/chest.06-2336.
citation: Katan M, Fluri F, Morgenthaler NG, Schuetz P, Zweifel C, Bingisser R, Muller K, Meckel S, Gass A, Kappos L, Steck AJ, Engelter ST, Muller B, Christ-Crain M. Copeptin: a novel, independent prognostic marker in patients with ischemic stroke. Ann Neurol. 2009 Dec;66(6):799-808. doi: 10.1002/ana.21783.