CClinicalTrials.gg
CompletedNCT01293318COPAUpdated Oct 25, 2016

Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis

An observational study in Acute Pancreatitis and Pancreatitis, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-25.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Pancreatitis
  • Pancreatitis

Keywords

  • Copeptin
  • Vasopressin
  • antidiuretic hormone (ADH)
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 150 is below the median of 180 across 277 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Exclusion Criteria:

  • time interval between onset of abdominal symptoms and study inclusion >96h
  • patients unable to consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Acute pancreatitis

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 hours

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

    Determinating Atlanta score, Sofa score. Assessing local complications by checking CT scan and searching for superinfection in fine needle aspiration and/or biopsy.

    Time frame: Duration of hospitalisation

  3. 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

    Time frame: Duration of hospitalisation

07

Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
08

References and documents

Publications

  • Morgenthaler NG, Muller B, Struck J, Bergmann A, Redl H, Christ-Crain M. Copeptin, a stable peptide of the arginine vasopressin precursor, is elevated in hemorrhagic and septic shock. Shock. 2007 Aug;28(2):219-26. doi: 10.1097/SHK.0b013e318033e5da. PubMed 17515850 ↗
  • Muller B, Morgenthaler N, Stolz D, Schuetz P, Muller C, Bingisser R, Bergmann A, Tamm M, Christ-Crain M. Circulating levels of copeptin, a novel biomarker, in lower respiratory tract infections. Eur J Clin Invest. 2007 Feb;37(2):145-52. doi: 10.1111/j.1365-2362.2007.01762.x. PubMed 17217381 ↗
  • Stolz D, Christ-Crain M, Morgenthaler NG, Leuppi J, Miedinger D, Bingisser R, Muller C, Struck J, Muller B, Tamm M. Copeptin, C-reactive protein, and procalcitonin as prognostic biomarkers in acute exacerbation of COPD. Chest. 2007 Apr;131(4):1058-67. doi: 10.1378/chest.06-2336. PubMed 17426210 ↗
  • Katan M, Fluri F, Morgenthaler NG, Schuetz P, Zweifel C, Bingisser R, Muller K, Meckel S, Gass A, Kappos L, Steck AJ, Engelter ST, Muller B, Christ-Crain M. Copeptin: a novel, independent prognostic marker in patients with ischemic stroke. Ann Neurol. 2009 Dec;66(6):799-808. doi: 10.1002/ana.21783. Erratum In: Ann Neurol. 2010 Feb;67(2):277-81. PubMed 20035506 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01293318
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Feb 10, 2011
Start date
Mar 2011
Primary completion
Nov 2015
Completion
Sep 2016
Last update
Oct 25, 2016

Study contacts

Christian A Nebiker, MD, Dr.
principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion