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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01293318
First received: February 9, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention
Acute Pancreatitis
Pancreatitis
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Copeptin Pancreatitis Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

Whole blood


Estimated Enrollment: 130
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)
Groups/Cohorts Assigned Interventions
Acute pancreatitis Other: No intervention
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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients presenting to the emergency departement or in-hospital patients with acute pancreatitis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293318

Contacts
Contact: Christian A Nebiker, MD, Dr. 0041613287649 nebikerc@uhbs.ch
Contact: Rachel Rosenthal, MD, Prof. 0041613287649 rosenthalr@uhbs.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Principal Investigator: Christian A Nebiker, MD, Dr.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christian A Nebiker, MD, Dr. University Hospital, Basel, Switzerland
  More Information

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01293318     History of Changes
Other Study ID Numbers: 281/10
Study First Received: February 9, 2011
Last Updated: January 24, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Copeptin
Vasopressin
ADH

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014