Transplant-Related DisorderNCT03448679
Albumin, COP and Endothelial Damage in Patients With ESLD Undergoing OLT
An observational study of Transplant-Related Disorder, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Transplant-Related Disorder
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2015to 6 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Child B/C Cirrhosis
- patients, who undergo the first OLT
Who cannot join
- re-transplant
- pregnancy
- inoperability
About this study
Official title: 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.
Read the 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.
- Conditions
- Transplant-Related Disorder
- Keywords
- glycocalyx, serum albumin, orthotopic liver transplantation, colloid osmotic pressure, endothelial dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
syndecan-1
marker for endothelial damage
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start6 Dec 2015
- Primary completion6 Dec 2016
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant-Related DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Peter Faybik, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448679
- Sponsor's protocol ID
- 2026/2015
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Albumin, Colloid Osmotic Pressure and Endothelial Damage in Patients With End Stage Liver Disease Undergoing Orthotopic Liver Transplantation. A Retrospective Data Analysis.
- ClinicalTrials.gov ID
- NCT03448679
- Acronym / sponsor ID
- 2026/2015
- Conditions
- Transplant-Related Disorder
- Keywords
- glycocalyx, serum albumin, orthotopic liver transplantation, colloid osmotic pressure, endothelial dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Dec 2015 (actual)
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Child B/C Cirrhosis
- patients, who undergo the first OLT
Key exclusion criteria (3 listed)
- re-transplant
- pregnancy
- inoperability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
syndecan-1
Time frame: 5 days
marker for endothelial damage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant-Related Disorder, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
syndecan-1 (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.