The Development of Pancreatic Injury in the Course of Severe Acute Respiratory Syndrome Coronavirus 2 Infection

June 15, 2020 updated by: Cevdet Duran, Uşak University

Pancreatic Injury in Patients With COVID-19 Disease

Although COVID-19 disease due to Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affects the respiratory tract, heart and coagulation system, symptoms of gastrointestinal system involvement such as abdominal pain, nausea, vomiting and diarrhea are also common.

In this study, it was aimed retrospective analysis of clinical and laboratory data of patients who developed pancreatic injury in the course of COVID 19 disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Usak, Turkey, 64200
        • Usak University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who develop amylase and lipase elevation during the course of COVID 19 will be considered in the pancreatic injury group. Those who do not develop will be counted as the control group.

Description

Inclusion Criteria:

  • Patients with amylase and lipase levels measured during covid-19 disease with or without pneumonia

Exclusion Criteria:

  • Patients with pregnancy
  • Patients whose amylase and lipase levels were not measured during covid 19 disease
  • Patients with known solid organ malignacy
  • Patients with known hematologic malignacy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with pancreatic injury
patients with higher amylase and lipase levels (higher than the laboratory upper limits) in the course of SARS-CoV-2 infection
Other: biochemical analysis
cRP, d-dimer levels and lymphocyte counts will be compared
patients without pancreatic injury
patients with normal amylase and lipase levels in the course of SARS-CoV-2 infection
Other: biochemical analysis
cRP, d-dimer levels and lymphocyte counts will be compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to compare presence of fever in patients with and without pancreatic injury
Time Frame: 3 month
To evaluate the frequency of presence of fever in patients with and without pancreatic injury
3 month
to compare presence of dyspnea in patients with and without pancreatic injury
Time Frame: 3 month
To evaluate the frequency of presence of dyspnea in patients with and without pancreatic injury
3 month
To compare cRP levels in patients with and without pancreatic injury
Time Frame: 3 month
CRP levels will be compared in patients with and without pancreatic injury
3 month
To compare d-dimer levels in patients with and without pancreatic injury
Time Frame: 3 month
D-Dimer levels will be compared in patients with and without pancreatic injury
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uşak University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

June 11, 2020

Study Completion (Actual)

June 12, 2020

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UsakU-Cevdet2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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