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

NCT01686776 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-19

No results posted yet for this study

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?

Conditions

  • Healthy
  • SIRS

Interventions

OTHER

123 I-HSA + 125 I HSA

Compare and validate the method of measuring albumine turnover rate

Sponsors & Collaborators

  • Ake Norberg

    lead OTHER

Principal Investigators

  • Olav Rooyackers, PhDProfessor · Karolinska University Hopsital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-27
Primary Completion
2013-06-01
Completion
2013-06-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01686776 on ClinicalTrials.gov