Study of Copeptin as a Diagnostic Marker for Acute Pancreatitis

NCT ID: NCT01293318

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

Acute Pancreatitis; Pancreatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute pancreatitis

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian A Nebiker, MD, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 17515850 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17217381 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17426210 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20035506 (View on PubMed)

Other Identifiers

281/10

Identifier Type: -

Identifier Source: org_study_id