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

NCT ID: NCT03448679

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-06

Study Completion Date

2016-12-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Transplant-Related Disorder

Keywords

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glycocalyx serum albumin orthotopic liver transplantation colloid osmotic pressure endothelial dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* re-transplant
* pregnancy
* inoperability
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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PD Peter Faybik, MD

Assoc.Prof. PD MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2026/2015

Identifier Type: -

Identifier Source: org_study_id