Incidence Of Hepatitis In Intensive Care Unit

• Sponsor: Sakarya University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03456037
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 33.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Unit	Other: hepatitis viruses

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 Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Incidence Of Hepatitis And Its Effect On Prognosis In Patients Who Follow In Intensive Care Unit
• Anticipated Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Outcome Measures

Primary Outcome Measures

1. HBsAg [1 month]

   HBsAg is the serologic hallmark of HBV infection and is the first marker to appear after acute infection.

Secondary Outcome Measures

1. anti-HCV [1mounth]

   Anti-HCV antibody tests look for antibodies to HCV in the blood, indicating an HCV infection has occurred.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

All patients who were followed in the intensive care unit

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sakarya University Research and Training Hospital	Sakarya		Turkey	54100

Sponsors and Collaborators

• Sakarya University

Investigators

• Study Chair: Havva Sayhan,, Assis Prof, Sakarya University Research and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Havva Sayhan, Assistant Professor, Sakarya University
• ClinicalTrials.gov Identifier: NCT03456037
• Other Study ID Numbers: hepatitis
• First Posted: Mar 7, 2018
• Last Update Posted: Mar 7, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Havva Sayhan, Assistant Professor, Sakarya University: HBsAg; Anti-HCV,; seropositivity
• Additional relevant MeSH terms: Hepatitis

Study Results

No Results Posted as of Mar 7, 2018