A Prospective Validation Study of Albumin Kinetics With Tracer 123 I-HSA

Healthy Clinical Trial

Official title:

A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686776
• Other study ID #: 3.00 # amended version 1.1
• Secondary ID: 2012-002638-35
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2012
• Last updated: February 15, 2018
• Start date: September 27, 2012
• Est. completion date: June 1, 2013

Study information

• Verified date: February 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, validation study of a extempore made tracer compared with a commercial. Studies with tracer have no medical effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation.

1. Primary Objective:

• Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identical values of calculated blood plasma volume and capillary leakage measured as transcapillary escape rate of albumin?

2. Secondary Objective:

• How do three different measures of albumin turnover correlate in volunteers?

• How do the pharmacokinetic parameters of endogenous albumin vary between the three study groups?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2013
• Est. primary completion date: June 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteers (treatment arm I)

• on contraceptive agent and/or contraceptive device

• visual peripheral veins

• signed informed consent

• planned for elective larger interabdominal surgery (treatment arm II)

• patients with a acute pancreatitis or cholecystitis (treatment arm III)

Exclusion Criteria:

• pregnant women and/or lactating

• allergy towards excipients in 123 I HSA or 125 I HSA

• participates in another study involving radiation or stabile isotopes within a period of 60 days to study start

• it is the opinion of the principle investigator that the patient/subject should not participate for his/hers own good

Related Conditions & MeSH terms

• Healthy
• SIRS

Intervention

Other:
• 123 I-HSA + 125 I HSA
Compare and validate the method of measuring albumine turnover rate

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Ake Norberg

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Komáromi A, Estenberg U, Hammarqvist F, Rooyackers O, Wernerman J, Norberg Å. Simultaneous assessment of the synthesis rate and transcapillary escape rate of albumin in inflammation and surgery. Crit Care. 2016 Nov 15;20(1):370. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	plasma albumin turnover rate	How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups?	42 days
Primary	Transcapillary Escape Rate (TER)of Albumin	Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)?	42 days
Secondary	Fractional catabolic rate (FCR)	Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate	42 days