NCT02893657

Brief Summary

The aim of the present study is the evaluation of the occurrence and effect of hepatic dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in liver haemodynamics in the early postoperative period.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4.4 years

First QC Date

August 30, 2016

Last Update Submit

January 7, 2022

Conditions

Cardiac SurgeryHepatic ImpairmentHeart Failure

Keywords

MELD scorehemodynamicsliver abnormalities

Outcome Measures

Primary Outcomes (3)

  • The composite of in-hospital death of any cause

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Length of hospital stay

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Length of ICU stay

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (6)

  • Evidence of clinically definite postoperative decline in hepatic function

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Need for reoperation due to bleeding or cardiac cause

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Evidence of clinically definite postoperative pulmonary or systemic congestion

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Evidence of clinically definite postoperative low cardiac output syndrome

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • Evidence of clinically definite postoperative acute kidney injury and the need for dialysis

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • +1 more secondary outcomes

Eligibility Criteria

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

Adult cardiac surgical patients

You may qualify if:

  • Patients over 18 years of age admitted for elective cardiac surgical procedures

You may not qualify if:

  • Not willing to participate.
  • Pregnant women.
  • During active psychiatric hospital care.
  • Patients with defined legal incapability or limited capability.
  • Non-evaluable patient due to insufficient clinical information
  • Patients with a transplanted heart.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Vascular Center, Semmelweis University

Budapest, 1122, Hungary

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Enikő Holndonner-Kirst, MD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

  • Andrea Székely, MD, PhD

    Semmelweis University

    STUDY DIRECTOR

  • Daniel Lex, MD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

  • Nikoletta Ráhel Czobor, MD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

  • Ádám Nagy, MD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

  • János Gál, MD, PhD

    Semmelweis University

    STUDY CHAIR

  • Béla Merkely, MD, PhD

    Semmelweis University

    STUDY CHAIR

Central Study Contacts

Andrea Székely, MD, PhD

CONTACT

+36206632243andi_szekely@yahoo.com

Enikő Holndonner-Kirst, MD

CONTACT

+36305058050kirst.eniko@gmail.com

Study Design

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

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 8, 2016

Study Start

December 1, 2017

Primary Completion

May 1, 2022

Study Completion

May 1, 2023

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)