Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— COPA  

Official title:

Copeptin Pancreatitis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293318
• Other study ID #: 281/10
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: October 24, 2016
• Start date: March 2011
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Katan M, Fluri F, Morgenthaler NG, Schuetz P, Zweifel C, Bingisser R, Müller K, Meckel S, Gass A, Kappos L, Steck AJ, Engelter ST, Müller 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. Erratum in: Ann Neurol. 2010 Feb;67(2):277-81. — View Citation

Morgenthaler NG, Müller 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. — View Citation

Müller B, Morgenthaler N, Stolz D, Schuetz P, Müller 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. — View Citation

Stolz D, Christ-Crain M, Morgenthaler NG, Leuppi J, Miedinger D, Bingisser R, Müller C, Struck J, Müller B, Tamm M. Copeptin, C-reactive protein, and procalcitonin as prognostic biomarkers in acute exacerbation of COPD. Chest. 2007 Apr;131(4):1058-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between copeptin level and severity of pancreatitis (according to Atlanta classification)	Copeptin level will be measured on admission into hospital and severity of pancreatitis will be classified according to the Atlanta criteria.	48 hours	No
Secondary	Comparison of copeptin with C reactive protein and procalcitonin in terms of assessing severity of pancreatitis		48 hours	No
Secondary	Predictive accuracy of copeptin, C reactive Protein (CRP) and procalcitonin in terms of developing organ failure, necrosis and/or superinfection and mortality	Determinating Atlanta score, Sofa score. Assessing local complications by checking CT scan and searching for superinfection in fine needle aspiration and/or biopsy.	Duration of hospitalisation	No
Secondary	Determine whether change in copeptin level from day 0 to 2 is associated with organ failure, necrosis and/or superinfection	To determine if the change in copeptin level is associated with organ failure, necrosis and superinfection	Duration of hospitalisation	No