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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-27

Study Completion Date

2013-06-01

Brief Summary

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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?

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Detailed Description

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Conditions

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Healthy SIRS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 parallell Groups were measured regarding plasma volume and transcapillary escape rate of albumin where commercial 125I-iodinated human serum albumin was compared to hospital manufactured 123I- iodinated human serum albumin

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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123 I-HSA + 125 I-HSA

Healthy Volunteers, N=16

Group Type ACTIVE_COMPARATOR

123 I-HSA + 125 I HSA

Intervention Type OTHER

Compare and validate the method of measuring albumine turnover rate

123 I- HSA + 125 I-HSA

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

Group Type EXPERIMENTAL

123 I-HSA + 125 I HSA

Intervention Type OTHER

Compare and validate the method of measuring albumine turnover rate

123-I-HSA+125 I-HSA

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

Group Type EXPERIMENTAL

123 I-HSA + 125 I HSA

Intervention Type OTHER

Compare and validate the method of measuring albumine turnover rate

Interventions

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123 I-HSA + 125 I HSA

Compare and validate the method of measuring albumine turnover rate

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes