Liver TransplantNCT01840514
Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.
An observational study of Liver Transplant, run by Mansoura University at 2 sites in Egypt.
Trial summary
The stress of orthotopic living donor liver transplantation in patients with cirrhosis could induce worsening of an already recorded myocardial dysfunction or may be associated with a new myocardial dysfunction in patients previously having normal myocardial functions, therefore this study will be designed for… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Liver Transplant
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2012to Sep 2015
- How long will I take part?
- 1 Day
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: recipient of living donor liver
Who may be able to join
- all adult recipient
Who cannot join
- massive blood transfusion
- grade III esophageal varices
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Liver transplantation program - Gastroenterology surgical center
Al Mansurah, Dakahlia Governorate, 35511
Amr M Yassen, MD, +201001497044, amryassen@hotmail.com
Waleed R alsarraf, MD, +201222322727, welsarraf@yahoo.com
- Recruiting
Liver transplantation project - Gastroenterology surgical center - Mansoura university
Al Mansurah, Dakahlia Governorate, 35511
Amr M Yassen, MD, +201001497044, amryassen@hotmail.com
Waleed R Elsarraf, MD, +201222322727, welsarraf@yahoo.com
About this study
The stress of orthotopic living donor liver transplantation in patients with cirrhosis could induce worsening of an already recorded myocardial dysfunction or may be associated with a new myocardial dysfunction in patients previously having normal myocardial functions, therefore this study will be designed for intra-operative detection of new onset ventricular dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver transplant recipient and the possible contribution of several hemodynamic and oxygenation parameters in the generation of any cardiovascular function impairment will be also investigated and to determine the impact of ventricular dysfunction on early (7 PO days) graft function, 28 days survival and patient outcomes.
- Conditions
- Liver Transplant
- Keywords
- recipient
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic monitoring
Measured: intraoperative
Secondary outcomes (1)
graft function
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Yassen, Mansoura University
- Investigators
- amr yassen, MD, Principal investigator, Liver transplant program, mansoura faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840514
- Sponsor's protocol ID
- 1982
- Status last verified
- Oct 2013
- First submitted
- 23 Apr 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.
- ClinicalTrials.gov ID
- NCT01840514
- Acronym / sponsor ID
- 1982
- Conditions
- Liver Transplant
- Keywords
- recipient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Apr 2013 (estimated)
- 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 stress of orthotopic living donor liver transplantation in patients with cirrhosis could induce worsening of an already recorded myocardial dysfunction or may be associated with a new myocardial dysfunction in patients previously having normal myocardial functions, therefore this study will be designed for intra-operative detection of new onset ventricular dysfunction or worsening of already diagnosed ventricular dysfunction in living donor liver transplant recipient and the possible contribution of several hemodynamic and oxygenation parameters in the generation of any cardiovascular function impairment will be also investigated and to determine the impact of ventricular dysfunction on early (7 PO days) graft function, 28 days survival and patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- recipient of living donor liver
Key inclusion criteria (1 listed)
- all adult recipient
Key exclusion criteria (2 listed)
- massive blood transfusion
- grade III esophageal varices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hemodynamic monitoring
Time frame: intraoperative
1 secondary outcome
graft function
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
amr yassen, MD principal investigator
Liver transplant program, mansoura faculty of medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, run by Mansoura University at 2 sites 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 2 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 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact amr M yassen, MD (+201001497044, amryassen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic monitoring (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2013.