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Completed

NCT Number: NCT01293318

Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis

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.

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Key information

Conditions

Acute Pancreatitis Diabetes Insipidus Digestive System Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pancreatic Diseases Pancreatitis Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Copeptin Pancreatitis Trial

Acronym: COPA

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Feb 10, 2011
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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