NCT01293318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

4.7 years

First QC Date

February 9, 2011

Last Update Submit

October 24, 2016

Conditions

Acute PancreatitisPancreatitis

Keywords

CopeptinVasopressinantidiuretic hormone (ADH)

Outcome Measures

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.

    48 hours

Secondary Outcomes (3)

  • 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

    Duration of hospitalisation

  • Determine whether change in copeptin level from day 0 to 2 is associated with organ failure, necrosis and/or superinfection

    Duration of hospitalisation

Study Arms (1)

Acute pancreatitis

Other: No intervention

Interventions

No interventionOTHER

No intervention

Acute pancreatitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to the emergency departement or in-hospital patients with acute pancreatitis

You may qualify if:

  • diagnosis of acute pancreatitis
  • written informed consent
  • inpatient treatment

You may not qualify if:

  • patients unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 17515850BACKGROUND

  • 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.

    PMID: 17217381BACKGROUND

  • 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.

    PMID: 17426210BACKGROUND

  • 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.

    PMID: 20035506BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

PancreatitisDiabetes Insipidus

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Christian A Nebiker, MD, Dr.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2015

Study Completion

September 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

CH(1)