How the body handle the plasma protein albumin in connection with liver transplantation, assessed by mass balance of albumi

Conditions: liver transplantation
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Registration Number: EUCTR2015-002568-18-SE

Lead Sponsor: Stockholm County Council, Karolinska University Hospital Huddinge, Department of Anesthesiology and Intensive Care

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Patients undergoing liver transplantation
• Males and females = 40 years
• Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Allergy to the investigational medical product
• Pregnancy or breast feeding patients
• Participation in other studies involving radiation or the use of stable isotopes within 30 days
• Bleeding > 5000 mL
• Re-transplantation, graft size reduction, or split liver
• Continuous renal replacement therapy
• Other circumstance that makes the investigator judge patient participation unsuitable.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To find if and to what extent albumin is sequestered from the blood stream during and after liver transplantation;Secondary Objective: To explore the recovery of liver protein synthesis after liver transplantation;Primary end point(s): Cumulative perioperative albumin shift assessed by albumin mass balance ;Timepoint(s) of evaluation of this end point: Measurements will begin in connection with start of anesthesia (baseline). The primary endpoint is assessed at the end of the surgical procedure (liver transplantation) and 48-72 hours later

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Albumin synthesis rate (fractional and absolute), fibrinogen synthesis rate (fractional and absolute), plasma albumin, plasma volume, transcapillary escape rate of albumin;Timepoint(s) of evaluation of this end point: plasma albumin: from start of anesthesia until 72 hours after end of surgery.<br>all other secondary endpoints during 48-72 hours after end of surgery.