Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis (COPA)
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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 |
- 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.
- 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 |
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
Contacts and Locations| Contact: Christian A Nebiker, MD, Dr. | 0041613287649 | nebikerc@uhbs.ch |
| Contact: Rachel Rosenthal, MD, Prof. | 0041613287649 | rosenthalr@uhbs.ch |
| Switzerland | |
| University Hospital Basel | Recruiting |
| Basel, Switzerland, 4031 | |
| Principal Investigator: Christian A Nebiker, MD, Dr. | |
| 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 Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013