Study of Oxidized Albumin in Liver Transplant Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Stockholm
About this trial
The overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. This is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. Samples for analysing the oxidation state of albumin, general oxidative damage and anti-oxidant state, the activation of the complement system and factors involved in coagulation will be obtained before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients on waiting list for liver transplantation
Disqualifiers
none
Trial population
Patient that are accepted for liver transplantation and put on the waiting list will be included
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Albumin quality
Describe potential qualitative changes in albumin during the liver transplantation procedure. Non-oxidised, single oxidised and double oxidised albumin will be analysed by HPLC.
Time frame
Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.Secondary outcomes
1
Effect of clinical factors on albumin quality before transplantation
Explore the impact of different clinical factors on albumin's oxidative state before transplantation. For this a multiple regression model will be used including clinical parameters; sex (male or female), age (years), and MELD (Model for end-stage liver disease).
Time frame
Before transplantation.2
Effect of clinical factors on albumin quality after transplantation
Explore the impact of different clinical factors on albumin's oxidative state after transplantation. For this a multiple regression model will be used including clinical parameters; sex (male or female), age (years), MELD (Model for end-stage liver disease), bleeding during surgery (in liters), time of surgery (hours).
Time frame
On postop days 1, 2 and about 30.3
Graft outcome in relation to albumin quality
Explore of the oxidation state of albumin (percentage of albumin that is oxidised) is correlated with graft function (bilirubin levels in mg/L)
Time frame
At days 1, 2 and about 30 days after transplantation4
Oxidative stress in relation to albumin quality
Explore is the oxidation state of albumin (percentage of albumin oxidised) is related to a general oxidative state measured by TBARS (Thiobarbituric acid reactive substances) measured as MDA (malondialdehydes) in nmol/ml.
Time frame
Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.Locations
Sponsors and contacts
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Region Stockholm
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: