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

October 24, 2016 updated by: University Hospital, Basel, Switzerland

Copeptin Pancreatitis Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of copeptin with C reactive protein and procalcitonin in terms of assessing severity of pancreatitis
Time Frame: 48 hours
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
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
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
Duration of hospitalisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christian A Nebiker, MD, Dr., University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 9, 2011

First Posted (Estimate)

February 10, 2011

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 281/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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