NCT03563404

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 29, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2016

Completed
2 years until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

May 3, 2016

Last Update Submit

July 2, 2018

Conditions

Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic Stability

    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 Outcomes (1)

  • correlation between the cardiac dysfunction and the degree of hyperkalemia seen after reperfusion.

    5 days

Study Arms (2)

Portal Blood Flush

participants that receive the portal blood flush

No Portal Blood Flush

participants that don't receive the portal blood flush

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Liver Transplant

You may qualify if:

  • Liver Transplantation
  • years old or older

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Grayce Davis, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

June 20, 2018

Study Start

June 29, 2015

Primary Completion

June 29, 2016

Study Completion

June 29, 2016

Last Updated

July 3, 2018

Record last verified: 2018-07

Locations

US(1)