Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis

Study Overview
=================
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.

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.

Official Title
-----------------
Copeptin Pancreatitis Trial

Conditions
-----------------
Acute Pancreatitis, Pancreatitis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute pancreatitis<br> | Other: No intervention<br>* No intervention<br>|

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) | 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 |  | 48 hours | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Copeptin, Vasopressin, antidiuretic hormone (ADH)