- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03563404
Portal Blood Flushes in the Peri-Reperfusion Stage of Liver Transplantation
July 2, 2018 updated by: Medical University of South Carolina
Are Portal Blood Flushes Useful in Maintaining Hemodynamic Stability in the Peri-Reperfusion Stage of Orthotopic Liver Transplantation
By showing that increased levels of acidotic metabolites and electrolytes in the systemic blood of patients who do not receive portal blood flush prior to reperfusion compared to patients who do receive portal blood flush, and that these increased levels correlate with cardiac depression as seen on TEE, the investigators hope to find a superior technique for liver reperfusion.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Liver Transplant
Description
Inclusion Criteria:
- Liver Transplantation
- 18 years old or older
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Portal Blood Flush
participants that receive the portal blood flush
|
No Portal Blood Flush
participants that don't receive the portal blood flush
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodynamic Stability
Time Frame: 5 days
|
The primary objective of this study is to determine whether or not a portal blood flush is useful for maintaining hemodynamic stability in the peri-reperfusion stage of Orthotopic Liver Transplantation as evidence by TEE.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation between the cardiac dysfunction and the degree of hyperkalemia seen after reperfusion.
Time Frame: 5 days
|
The secondary objective is to determine if there is a correlation between cardiac dysfunction as measured by a qualitative analysis of TEE and the degree of hyperkalemia measured by a post reperfusion blood sample.
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Grayce Davis, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 29, 2015
Primary Completion (Actual)
June 29, 2016
Study Completion (Actual)
June 29, 2016
Study Registration Dates
First Submitted
May 3, 2016
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
July 3, 2018
Last Update Submitted That Met QC Criteria
July 2, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00044952
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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