NCT03633812

Brief Summary

This is prospective cohort study of patients classified by the premedication history of beta-blocker. The investigators aim to evaluate the hemodynamic effect of beta blocker through Swan-Ganz catheter monitoring and arterial pressure waveform analysis during surgery. The investigators also plan to observe the long-term effects of beta blocker on acute renal failure, allograft failure and mortality.

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
477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 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

October 28, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

August 14, 2018

Last Update Submit

August 21, 2018

Conditions

End Stage Liver DiseaseAcute Kidney Injury

Keywords

End Stage Liver DiseaseAcute Kidney InjuryBeta blocker

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    Creatinine change

    1 week

Secondary Outcomes (2)

  • Graft failure

    1 year

  • Mortality

    1 year

Study Arms (2)

Beta blocker group

ESLD recipients who had beta blocker during more than 1 month before the liver transplantation

Other: Observational study, Beta blocker medication history

Non-Beta blocker group

ESLD recipients who had not taken beta blocker more than 3 month before the liver transplantation

Interventions

Observational study, Beta blocker medication historyOTHER

Observational study, Beta blocker medication history

Beta blocker group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

living donor liver transplant recipients at Asan Medical Center, Seoul, Korea, Republic of

You may qualify if:

  • living donor liver transplantation recipients

You may not qualify if:

  • previous history of acute kidney injury
  • previous liver transplantation history
  • Fulminant hepatic failure
  • history of TIPS, transjugular intrahepatic porto-systemic shunt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Asan medical center

Seoul, South Korea

RECRUITING

Related Publications (3)

  • Krag A, Wiest R, Albillos A, Gluud LL. The window hypothesis: haemodynamic and non-haemodynamic effects of beta-blockers improve survival of patients with cirrhosis during a window in the disease. Gut. 2012 Jul;61(7):967-9. doi: 10.1136/gutjnl-2011-301348. Epub 2012 Jan 10. No abstract available.

    PMID: 22234982BACKGROUND

  • Serste T, Melot C, Francoz C, Durand F, Rautou PE, Valla D, Moreau R, Lebrec D. Deleterious effects of beta-blockers on survival in patients with cirrhosis and refractory ascites. Hepatology. 2010 Sep;52(3):1017-22. doi: 10.1002/hep.23775.

    PMID: 20583214BACKGROUND

  • Serste T, Francoz C, Durand F, Rautou PE, Melot C, Valla D, Moreau R, Lebrec D. Beta-blockers cause paracentesis-induced circulatory dysfunction in patients with cirrhosis and refractory ascites: a cross-over study. J Hepatol. 2011 Oct;55(4):794-9. doi: 10.1016/j.jhep.2011.01.034. Epub 2011 Feb 24.

    PMID: 21354230BACKGROUND

MeSH Terms

Conditions

End Stage Liver DiseaseAcute Kidney Injury

Interventions

Observation

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Jun Gol Song, PH.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Won Jeong, M.D.

CONTACT

82-10-2531-9131jklm110303@gmail.com

Study Design

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

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 16, 2018

Study Start

October 28, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)