Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03830060
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Reham I El-mahdy, Assiut University

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.

Condition or disease Intervention/treatment
Acute Pancreatitis Diagnostic Test: Measurement of cortisol

Detailed Description:

Severe acute pancreatitis is one of the most common acute abdomens in clinical practice. Owing to its acute onset, rapid progress, and high mortality, it has become a hot clinical study spot and one of the toughest medical problems. Markers of inflammation, such as high-sensitivity CRP (hs-CRP), are predictive of the severity of acute pancreatitis and may be useful in identifying patients with severe acute pancreatitis in the early phase after onset.

Antinuclear antibodies (ANA) are important biomarkers for the autoimmune disorder. ANA may contribute to the pathogenesis of pancreatitis and ANA positivity is associated with the presence of autoimmune pancreatitis. Cortisol is released into the blood due to stimulation of corticotrophin receptors in the adrenal cortex. Thus, serum cortisol can be measured. Although the association between serum levels of some inflammatory marker and acute pancreatitis revealed, the relationship between ANA, cortisol, hs-CRP and with the severity of acute pancreatic lesions have not evaluated yet.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Diagnostic and Prognostic Evaluation of Acute Pancreatitis
Estimated Study Start Date : February 25, 2019
Estimated Primary Completion Date : May 20, 2019
Estimated Study Completion Date : May 30, 2019


Group/Cohort Intervention/treatment
Group I:
Fifty AP patients on admission
Diagnostic Test: Measurement of cortisol
Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP

Group II:
The previous AP patients after 72 hours
Diagnostic Test: Measurement of cortisol
Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP




Primary Outcome Measures :
  1. The mean difference of cortisol before and after treatment [ Time Frame: 72 hours ]
    Cortisol mean difference will be measured by immunofluorescence in acute pancreatitis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute pancreatitis
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830060


Contacts
Layout table for location contacts
Contact: reham elmahdy +201002714637 reham.elmahdy@aun.edu.eg

Sponsors and Collaborators
Assiut University

Publications:
Layout table for additonal information
Responsible Party: Reham I El-mahdy, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03830060     History of Changes
Other Study ID Numbers: Pancreatitis
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reham I El-mahdy, Assiut University:
Marker of inflammation
high-sensitivity CRP
Antinuclear antibodies
Cortisol

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Pancreatitis
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases
Antibodies
Immunoglobulins
Antibodies, Antinuclear
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents