- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456037
Incidence Of Hepatitis In Intensive Care Unit
March 6, 2018 updated by: Havva Sayhan, Sakarya University
Incidence Of Hepatitis And Its Effect On Prognosis In Patients Who Follow In Intensive Care Unit
The aim is to investigate incidence of HBsAg, anti-HCV in serum samples and evaluation of biomarkers taken from patients who were followed the intensive care unit of Sakarya University Training and Research Hospital and The intensive care unit attracts attention by making health workers more susceptible to the risk of hepatitis.
Study Overview
Detailed Description
This retrospective study included 536 cases who were followed with various diagnoses in intensive care units between 1 Ocak 2015 ile 1 Ocak 2016, covering the six months period, retrospectively.
Sakarya University's Faculty of Medicine Review Board (71522473/050.01.04/113) approved the study after approval of the research ethics committee (.
Medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, HBsAg, anti-HCV, AST, ALT, bilirubin, creatinine levels.
Study Type
Observational
Enrollment (Anticipated)
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
-
-
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Sakarya, Turkey, 54100
- Recruiting
- Sakarya University Research and Training hospital
-
Contact:
- Havva Sayhan, Assis Prof
- Phone Number: +905056621021
- Email: hsayhan@gmail.com
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-
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
18 years to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study was conducted from 1 january 2015 to 1 january 2016 .
Patients who were followed with various diagnoses in intensive care units between 1 january 2015 to 1 january 2016, covering the one year period, retrospectively.
Description
Inclusion Criteria:
All patients who were followed in the intensive care unit
Exclusion Criteria:
None
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HBsAg
Time Frame: 1 month
|
HBsAg is the serologic hallmark of HBV infection and is the first marker to appear after acute infection.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anti-HCV
Time Frame: 1mounth
|
Anti-HCV antibody tests look for antibodies to HCV in the blood, indicating an HCV infection has occurred.
|
1mounth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Havva Sayhan,, Assis Prof, Sakarya University Research and Training hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Anticipated)
April 1, 2018
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
February 28, 2018
First Submitted That Met QC Criteria
March 6, 2018
First Posted (Actual)
March 7, 2018
Study Record Updates
Last Update Posted (Actual)
March 7, 2018
Last Update Submitted That Met QC Criteria
March 6, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hepatitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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