Factors associated with the synthesis rate of the plasma protein albumin in patients with severe chronic liver failure.

Phase 1

• Conditions: Severe chronic liver failure; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2015-002567-42-SE
• Lead Sponsor: Stockholm County Council, Karolinska University Hospital Huddinge, Dept of Anesthesiology and Intensive Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

• Patients referred to Center for Digestive Diseases at Karolinska University Hospital Huddinge, as Child-Pugh B or C, for assessment of suitability for liver transplantation. At least 10 patients with Child-Pugh C will be included.
• 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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Patients assessed for liver transplantation but with less severe liver failure, referred as Child-Pugh A
• Pregnancy or breast feeding patients
• Allergy to the investigational medical product
• Participation in other studies involving radiation or the use of stable isotopes within 30 days
• Paracentesis or gastrointestinal bleeding the last 7 days
• 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 which of the following factors that predict albumin synthesis rate in patients with chronic liver failure: Child-Pugh score, MELD score, individual components of these two scores, respectively, indices of inflammation (P-ferritin, P-CRP), indices portal hypertension (splenomegaly, esophageal varices, platelet count), indices of coagulation (tromboelastometri), lactate clearance or dietary assessment.;<br> Secondary Objective: • To characterize how the above mentioned factors and albumin synthesis rate correlate to capillary leakage measured by transcapillary escape rate of albumin.<br> • To characterize how do these same factors correlate to fibrinogen synthesis.<br> • To improve the prediction of impaired albumin synthesis rate by multiple linear regression.<br> ;Primary end point(s): Albumin synthesis rate (fractional and absolute, respectively);Timepoint(s) of evaluation of this end point: Blood sampling for 90 min on study day

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Albumin and fibrinogen parameters and lactate clearance during the same 90 min the study day as the primary endpoint. All other parameters as close in time as pragmatically possible.;Secondary end point(s): Child-Pugh score and MELD score, and components thereof, respectively, P-albumin, plasma volume, Transcapillary escape rate of albumin, fibrinogen synthesis rate, lactate clearance, P-fibrinogen, P-CRP, P-ferritin, blood platelet count, dietary assessment, nutrition status, splenomegaly, esophageal varices, and components of tromboelastometri.