NCT03830060

Brief Summary

Acute pancreatitis (AP) is a potentially life-threatening disease with varying severity of presentation. Nearly 60%-80% of all cases of AP in developed countries are attributable to either gallstone disease or alcohol abuse. The incidence is similar in both sexes, although alcohol abuse is the more common cause in men and gallstones is the more common cause in women.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Status
unknown

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 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

February 25, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 2, 2019

Last Update Submit

February 2, 2019

Conditions

Keywords

Marker of inflammationhigh-sensitivity CRPAntinuclear antibodiesCortisol

Outcome Measures

Primary Outcomes (1)

  • The mean difference of cortisol before and after treatment

    Cortisol mean difference will be measured by immunofluorescence in acute pancreatitis.

    72 hours

Study Arms (2)

Group I:

Fifty AP patients on admission

Diagnostic Test: Measurement of cortisol

Group II:

The previous AP patients after 72 hours

Diagnostic Test: Measurement of cortisol

Interventions

Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP

Group I:Group II:

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Acute pancreatitis

You may qualify if:

  • abdominal pain consistent with AP
  • serum amylase activity at least 3 times greater than the upper limit of normal
  • Patients of age 18 years or more who are willing to participate in the study and give their consent for same.

You may not qualify if:

  • Patients with severe liver disease, pulmonary embolus, sepsis, and renal failure were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Zhang XP, Zhang L, Wang Y, Cheng QH, Wang JM, Cai W, Shen HP, Cai J. Study of the protective effects of dexamethasone on multiple organ injury in rats with severe acute pancreatitis. JOP. 2007 Jul 9;8(4):400-12.

    PMID: 17625291BACKGROUND
  • Imamura T, Tanaka S, Yoshida H, Kitamura K, Ikegami A, Takahashi A, Niikawa J, Mitamura K. Significance of measurement of high-sensitivity C-reactive protein in acute pancreatitis. J Gastroenterol. 2002;37(11):935-8. doi: 10.1007/s005350200157.

    PMID: 12483249BACKGROUND
  • Nebiker CA, Staubli S, Schafer J, Bingisser R, Christ-Crain M, Dell-Kuster S, Mueller C, Scamardi K, Viehl CT, Kolleth D, von Holzen U, Oertli D, Rosenthal R. Cortisol Outperforms Novel Cardiovascular, Inflammatory, and Neurohumoral Biomarkers in the Prediction of Outcome in Acute Pancreatitis. Pancreas. 2018 Jan;47(1):55-64. doi: 10.1097/MPA.0000000000000962.

    PMID: 29215538BACKGROUND
  • Smyk DS, Rigopoulou EI, Koutsoumpas AL, Kriese S, Burroughs AK, Bogdanos DP. Autoantibodies in autoimmune pancreatitis. Int J Rheumatol. 2012;2012:940831. doi: 10.1155/2012/940831. Epub 2012 Jul 12.

    PMID: 22844291BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

February 25, 2019

Primary Completion

May 20, 2019

Study Completion

May 30, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02