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

Predictors of albumin synthesis rate in severe liver failure. An open exploratory study in patients with chronic liver failure assessed for liver transplantation - Albumin synthesis in liver failure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002567-42-SE

Enrollment

Registered

2015-06-15

Start date

2015-07-15

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe chronic liver failure

Interventions

Trade Name: SERALB-125 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: • To characterize how the above mentioned factors and albumin synthesis rate correlate to capillary leakage measured by transcapillary escape rate of albumin. • To characterize how do these same factors correlate to fibrinogen synthesis. • To improve the prediction of impaired albumin synthesis rate by multiple linear regression. ;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	—

Measure

Time frame

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.; Secondary Objective: • To characterize how the above mentioned factors and albumin synthesis rate correlate to capillary leakage measured by transcapillary escape rate of albumin. • To characterize how do these same factors correlate to fibrinogen synthesis. • To improve the prediction of impaired albumin synthesis rate by multiple linear regression. ;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

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Sweden

Contacts

Public ContactDepartment of Anesthesiology

Karolinska Institutet, Institution CLINTEC

ake.norberg@karolinska.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026