Intensive Care UnitNCT03456037
Incidence Of Hepatitis In Intensive Care Unit
An observational study of Intensive Care Unit, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- hepatitis viruses
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients who were followed in the intensive care unit
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University Research and Training Hospital
Sakarya, 54100
Havva Sayhan, Assis Prof, +905056621021, hsayhan@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intensive Care Unit
- Being tested
- hepatitis viruses
- Keywords
- HBsAg, Anti-HCV,, seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis virusesOther
There are 5 main hepatitis viruses, referred to as types A, B, C, D and E. These 5 types are of greatest concern because of the burden of illness and death they cause and the potential for outbreaks and epidemic spread. In particular, types B and C lead to chronic disease in hundreds of millions of people and, together, are the most common cause of liver cirrhosis and cancer.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.
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg
HBsAg is the serologic hallmark of HBV infection and is the first marker to appear after acute infection.
Measured: 1 month
Secondary outcomes (1)
anti-HCV
Anti-HCV antibody tests look for antibodies to HCV in the blood, indicating an HCV infection has occurred.
Measured: 1mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Sayhan, Sakarya University
- Investigators
- Havva Sayhan,, Assis Prof, Study chair, Sakarya University Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456037
- Sponsor's protocol ID
- hepatitis
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dayan S, Tekin A, Tekin R, Dal T, Hosoglu S, Yazgan UC, Bekcibasi M, Gul K. HBsAg, anti-HCV, anti-HIV 1/2 and syphilis seroprevalence in healthy volunteer blood donors in southeastern Anatolia. J Infect Dev Ctries. 2013 Sep 16;7(9):665-9. doi: 10.3855/jidc.2835.
PubMed 24042102
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence Of Hepatitis And Its Effect On Prognosis In Patients Who Follow In Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03456037
- Acronym / sponsor ID
- hepatitis
- Conditions
- Intensive Care Unit
- Keywords
- HBsAg, Anti-HCV,, seropositivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who were followed in the intensive care unit
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatitis virusesThere are 5 main hepatitis viruses, referred to as types A, B, C, D and E. These 5 types are of greatest concern because of the burden of illness and death they cause and the potential for outbreaks and epidemic spread. In particular, types B and C lead to chronic disease in hundreds of millions of people and, together, are the most common cause of liver cirrhosis and cancer.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. | Other | – |
Primary outcome
HBsAg
Time frame: 1 month
HBsAg is the serologic hallmark of HBV infection and is the first marker to appear after acute infection.
1 secondary outcome
anti-HCV
Time frame: 1mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Results publication: PubMed 24042102Dayan S, Tekin A, Tekin R, Dal T, Hosoglu S, Yazgan UC, Bekcibasi M, Gul K. HBsAg, anti-HCV, anti-HIV 1/2 and syphilis seroprevalence in healthy volunteer blood donors in southeastern Anatolia. J Infect Dev Ctries. 2013 Sep 16;7(9):665-9. doi: 10.3855/jidc.2835.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Havva Sayhan,, Assis Prof study chair
Sakarya University Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Havva Sayhan,, Assis Prof (+905056621021, hsayhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03456037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.