Effect of Bacterial TranslocationNCT03230214
Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During Liver Transplantation
An observational study of Effect of Bacterial Translocation, run by Alexandria University at 1 site in Egypt.
Trial summary
The present study is to demonstrate the effect of the presence of bacterial translocation detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a liver transplant procedure. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Effect of Bacterial Translocation
- What is being tested?
- PCR for bacterial translocation
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2017to 14 Nov 2017
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: adult patients with grade C liver cirrhosis with liver failure undergoing liver transplantation
Who may be able to join
- patients with liver failure undergoing liver transplantation
Who cannot join
- Age less than 18 years;
- Active overt infection;
- Patients on oral or systemic anticoagulation or with known coagulopathic disorders apart from those caused by liver failure (eg.: Protein C or S deficiency, congenital platelet disorders and congenital coagulation disorders…etc);
- Patients undergoing re-transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During a Liver Transplantation
The present study is to demonstrate the effect of the presence of bacterial translocation detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a liver transplant procedure.
- Conditions
- Effect of Bacterial Translocation
- Being tested
- PCR for bacterial translocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR for bacterial translocationDiagnostic test
samples taken from the blood and ascites of patients to search for bacterial DNA
| Study group | Role | What they receive |
|---|---|---|
| DNA positive patients | patients who have bacterial DNA in their samples Receives: Diagnostic Test: PCR for bacterial translocation | |
| DNA negative patients | patients who do not have bacterial DNA in their samples Receives: Diagnostic Test: PCR for bacterial translocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the mean arterial blood pressure
Measured: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
antifactor X activity
Measured: at the beginning of surgery
change in the heart rate
Measured: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
change in the cardiac output
Measured: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start3 Aug 2017
- Primary completion24 Oct 2017
- Study completion14 Nov 2017
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 Effect of Bacterial TranslocationStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Moharem, Alexandria University
- Investigators
- ahmed mukhtar, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230214
- Sponsor's protocol ID
- 020583
- Status last verified
- Jan 2018
- First submitted
- 20 Jul 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Moharem HA, Fetouh FA, Darwish HM, Ghaith D, Elayashy M, Hussein A, Elsayed R, Khalil MM, Abdelaal A, ElMeteini M, Mukhtar A. Effects of bacterial translocation on hemodynamic and coagulation parameters during living-donor liver transplant. BMC Anesthesiol. 2018 Apr 25;18(1):46. doi: 10.1186/s12871-018-0507-7.
PubMed 29699477
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bacterial Translocation on Haemodynamic and Coagulation Parameters During a Liver Transplantation
- ClinicalTrials.gov ID
- NCT03230214
- Acronym / sponsor ID
- 020583
- Conditions
- Effect of Bacterial Translocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 26 Jul 2017 (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 present study is to demonstrate the effect of the presence of bacterial translocation detected by bacterial deoxyribonucleic acid (bactDNA) in blood and ascites using the polymerase chain reaction (PCR) on some haemodynamic and coagulation parameters during a liver transplant procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNA positive patients | – | Diagnostic Test: PCR for bacterial translocationpatients who have bacterial DNA in their samples |
| DNA negative patients | – | Diagnostic Test: PCR for bacterial translocationpatients who do not have bacterial DNA in their samples |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patients with grade C liver cirrhosis with liver failure undergoing liver transplantation
Key inclusion criteria (1 listed)
- patients with liver failure undergoing liver transplantation
Key exclusion criteria (4 listed)
- Age less than 18 years;
- Active overt infection;
- Patients on oral or systemic anticoagulation or with known coagulopathic disorders apart from those caused by liver failure (eg.: Protein C or S deficiency, congenital platelet disorders and congenital coagulation disorders…etc);
- Patients undergoing re-transplantation.
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 |
|---|---|---|
| PCR for bacterial translocationsamples taken from the blood and ascites of patients to search for bacterial DNA | Diagnostic test | DNA negative patients, DNA positive patients |
Primary outcome
change in the mean arterial blood pressure
Time frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
antifactor X activity
Time frame: at the beginning of surgery
change in the heart rate
Time frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
change in the cardiac output
Time frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Derived from this study: PubMed 29699477Moharem HA, Fetouh FA, Darwish HM, Ghaith D, Elayashy M, Hussein A, Elsayed R, Khalil MM, Abdelaal A, ElMeteini M, Mukhtar A. Effects of bacterial translocation on hemodynamic and coagulation parameters during living-donor liver transplant. BMC Anesthesiol. 2018 Apr 25;18(1):46. doi: 10.1186/s12871-018-0507-7.
- Individual participant dataSharing planned: Undecided
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.
ahmed mukhtar, MD study director
Cairo University
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 Effect of Bacterial Translocation, run by Alexandria University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 17 Jan 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the mean arterial blood pressure (time frame: at the beginning of surgery then 15 nim after dissection then 15 min after the anhepatic phase then 15 min at the reperfusion phase). The study lists 4 primary outcomes in all. 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 NCT03230214, 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 17 Jan 2018.