Albumin, COP and Endothelial Damage in Patients With ESLD Undergoing OLT

February 22, 2018 updated by: PD Peter Faybik, MD, Medical University of Vienna

Serum Albumin, Colloid Osmotic Pressure and Endothelial Damage in Patients With End Stage Liver Disease Undergoing Orthotopic Liver Transplantation. A Retrospective Data Analysis.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Patients suffering from end-stage liver disease (ESLD) are critically ill. Still, therapeutic options are limited, no organ replacement procedure is available and orthotopic liver transplantation remains the unique therapy of choice.

ESLD is associated with a myriad of comorbidities, and is characterized by imbalances in the acid-base- status, coagulopathy, metabolic disorders and activation of the pro-inflammatory cascade. ESLD represents a state of generalized systemic inflammation subsequently leading to endothelial dysfunction and capillary leak syndrome, potentially culminating in end-organ dysfunction.

Furthermore, patients with ESLD suffer from reduced regenerative and synthetic capacity/ability, which is reflected by the serum albumin deficiency. Serum albumin is the most important plasma protein, is produced exclusively in the liver, and houses various physiological functions: it owns immunological, immuno-modulating and anti-inflammatory properties, transport capacities, as well as detoxifying qualities. However, the most well known property of human serum albumin is maintaining the colloid osmotic pressure (COP). In the healthy individual, serum albumin is responsible for 75% up to 80% of the COP, whereas in the critically ill, the percentage proportion drops down to 17%. The COP itself accounts for the regulation and distribution of the plasma volume and is therefore essential in maintaining the vascular stability and integrity. Additionally, the endothelial glycocalyx is necessary in the context of safeguarding the endothelial function and regulating the vascular permeability. The glycocalyx covers the endothelium luminally and its core component is the heparan sulfate proteoglycan, syndecan-1. Under various clinical conditions, like ischemia/reperfusion, inflammation, sepsis, shock, major surgery, hypervolemia, degradation to the glycocalyx may happen. These pathophysiological circumstances may lead to loss of the endothelial integrity and consecutively to capillary-leak syndrome causing a loss of albumin and fluid extravasation/shifts. Various clinical and experimental studies could show that global, as well as regional ischemia and the subsequent reperfusion-phase, both lead to glycocalyx-shedding, in terms of increased syndecan-1 plasma levels. Furthermore, a previous study from our study group clearly detected increased syndecan-1 plasma levels in patients with ESLD as surrogate parameter of glycocalyx degradation mirroring the state of chronic inflammation in this patient population.

Nevertheless, a clear correlation between colloid osmotic pressure, albumin and the loss of vascular integrity in state of endothelial dysfunction has not been studied before in patients with ESLD undergoing OLT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • re-transplant
  • pregnancy
  • inoperability

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
syndecan-1
Time Frame: 5 days
marker for endothelial damage
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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