Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis (COPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293318
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Pancreatitis Pancreatitis Other: No intervention

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 Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin Pancreatitis Trial
Study Start Date : March 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Acute pancreatitis Other: No intervention
No intervention

Primary Outcome Measures :
  1. Association between copeptin level and severity of pancreatitis (according to Atlanta classification) [ Time Frame: 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 :
  1. Comparison of copeptin with C reactive protein and procalcitonin in terms of assessing severity of pancreatitis [ Time Frame: 48 hours ]
  2. 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 ]
    Determinating Atlanta score, Sofa score. Assessing local complications by checking CT scan and searching for superinfection in fine needle aspiration and/or biopsy.

  3. 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 ]
    To determine if the change in copeptin level is associated with organ failure, necrosis and superinfection

Biospecimen Retention:   Samples With DNA
Whole blood

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the emergency departement or in-hospital patients with acute pancreatitis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01293318

University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Christian A Nebiker, MD, Dr. University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT01293318     History of Changes
Other Study ID Numbers: 281/10
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by University Hospital, Basel, Switzerland:
antidiuretic hormone (ADH)

Additional relevant MeSH terms:
Diabetes Insipidus
Pancreatic Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs