NCT01840514

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

April 23, 2013

Last Update Submit

October 4, 2013

Conditions

Liver Transplant

Keywords

recipient

Outcome Measures

Primary Outcomes (1)

  • hemodynamic monitoring

    intraoperative

Secondary Outcomes (1)

  • graft function

    7 days

Other Outcomes (1)

  • survival

    28 days

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

recipient of living donor liver

You may qualify if:

  • all adult recipient

You may not qualify if:

  • massive blood transfusion
  • grade III esophageal varices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liver transplantation program - Gastroenterology surgical center

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Liver transplantation project - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Study Officials

  • amr yassen, MD

    Liver transplant program, mansoura faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

amr M yassen, MD

CONTACT

+201001497044amryassen@hotmail.com

Waleed R Elsarraf, MD

CONTACT

+201222322727welsarraf@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 25, 2013

Study Start

December 1, 2012

Primary Completion

April 1, 2015

Study Completion

September 1, 2015

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

EG(2)