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

Ake Norberg

Status and phase: Completed; Phase 3

Conditions: Healthy; SIRS

Treatments: Other: 123 I-HSA + 125 I HSA

Study type: Interventional

Funder types: Other

Identifiers

NCT01686776

3.00 # amended version 1.1

2012-002638-35 (EudraCT Number)

Details and patient eligibility

About

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?

Enrollment: 30 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

123 I-HSA + 125 I-HSA

Active Comparator group

Description:

Healthy Volunteers, N=16

Treatment:

Other: 123 I-HSA + 125 I HSA

123 I- HSA + 125 I-HSA

Experimental group

Description:

Patients, planned for elective Major Abdominal Surgery, N=16

Treatment:

Other: 123 I-HSA + 125 I HSA

123-I-HSA+125 I-HSA

Experimental group

Description:

Patients, with a acute pancreatitis or cholecystitis, N=16

Treatment:

Other: 123 I-HSA + 125 I HSA