Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Amr Mohamed Yassen, Mansoura University
ClinicalTrials.gov Identifier:
NCT01840514
First received: April 23, 2013
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition
Liver Transplant

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Cardiac Functions in Living Donor Liver Transplant Recipients. An Echocardiographic Study.

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • hemodynamic monitoring [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • graft function [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • survival [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

recipient of living donor liver

Criteria

Inclusion Criteria:

  • all adult recipient

Exclusion Criteria:

  • massive blood transfusion
  • grade III esophageal varices
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840514

Contacts
Contact: amr M yassen, MD +201001497044 amryassen@hotmail.com
Contact: Waleed R Elsarraf, MD +201222322727 welsarraf@yahoo.com

Locations
Egypt
Liver transplantation program - Gastroenterology surgical center Recruiting
Mansoura, Dakahlia, Egypt, 35511
Contact: Amr M Yassen, MD    +201001497044    amryassen@hotmail.com   
Contact: Waleed R alsarraf, MD    +201222322727    welsarraf@yahoo.com   
Principal Investigator: Amr Yassen, MD         
Liver transplantation project - Gastroenterology surgical center - Mansoura university Recruiting
Mansoura, Dakahlia, Egypt, 35511
Contact: Amr M Yassen, MD    +201001497044    amryassen@hotmail.com   
Contact: Waleed R Elsarraf, MD    +201222322727    welsarraf@yahoo.com   
Sub-Investigator: Amr M Yassen, MD         
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: amr yassen, MD Liver transplant program, mansoura faculty of medicine
Principal Investigator: Amr yassen, MD Liver transplant program, mansoura faculty of medicine
Principal Investigator: Amr yassen, MD LIVER transplant program, mansoura faculty of medicine
  More Information

No publications provided

Responsible Party: Amr Mohamed Yassen, professor, Mansoura University
ClinicalTrials.gov Identifier: NCT01840514     History of Changes
Other Study ID Numbers: 1982
Study First Received: April 23, 2013
Last Updated: October 4, 2013
Health Authority: Egypt: mansoura faculty of medicine

Keywords provided by Mansoura University:
recipient

ClinicalTrials.gov processed this record on August 19, 2014