NCT03448679

Brief Summary

To study the correlation between colloid osmotic pressure, albumin and the loss of vascular integrity in terms of endothelial dysfunction in patients with ESLD undergoing OLT and its impact on the perioperative course, as well as on morbidity and mortality.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

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

December 6, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 22, 2018

Last Update Submit

February 22, 2018

Conditions

Transplant-Related Disorder

Keywords

glycocalyxserum albuminorthotopic liver transplantationcolloid osmotic pressureendothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • syndecan-1

    marker for endothelial damage

    5 days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients between 18 years and 80 years suffering from Child B/C Cirhhosis, who underwent OLT at the Medical University of Vienna in the period between 2014 and 2016.

You may qualify if:

  • Child B/C Cirrhosis
  • patients, who undergo the first OLT

You may not qualify if:

  • re-transplant
  • pregnancy
  • inoperability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum-samples for detection of syndecan-1 concentration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof. PD MD

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

December 6, 2015

Primary Completion

December 6, 2016

Study Completion

December 6, 2016

Last Updated

February 28, 2018

Record last verified: 2018-02