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

NCT01686776 — Phase 3, Completed, 30 participants, Ake Norberg

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

Registry	NCT01686776
Status	Completed
Phase	Phase 3
Study type	Interventional; non randomized, parallel, masking: none, other
Enrollment	30 (Actual)
Sponsor	Ake Norberg (Other)
Conditions	Healthy, SIRS
Interventions	123 I-HSA + 125 I HSA (Other)
Dates	start 2012-09-27, primary completion 2013-06-01, completion 2013-06-01, first posted 2012-09-18, last updated 2018-02-19
Locations	1 site in Sweden

-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?

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+Arms and interventions

Arm	Type	Interventions	Description
123 I-HSA + 125 I-HSA	Active comparator	Other: 123 I-HSA + 125 I HSA	Healthy Volunteers, N=16
123 I- HSA + 125 I-HSA	Experimental	Other: 123 I-HSA + 125 I HSA	Patients, planned for elective Major Abdominal Surgery, N=16
123-I-HSA+125 I-HSA	Experimental	Other: 123 I-HSA + 125 I HSA	Patients, with a acute pancreatitis or cholecystitis, N=16

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

+Outcome measures

Primary outcomes

Transcapillary Escape Rate (TER)of Albumin [42 days]: Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)?

Secondary outcomes

Fractional catabolic rate (FCR) [42 days]: Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate

Other outcomes

plasma albumin turnover rate [42 days]: How well does the variables FSR, FCR1, FCR30 correlate? How does the pharmacokinetic parameters differ/varies between the three groups?

+Eligibility

Sex: All, ages: 40 Years to any, 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

+Locations (1)

Facility	City	Country	Status
Karolinska University Hospital, Huddinge	Stockholm	Sweden

+Publications

Results publication: Komaromi A, Estenberg U, Hammarqvist F, Rooyackers O, Wernerman J, Norberg A. Simultaneous assessment of the synthesis rate and transcapillary escape rate of albumin in inflammation and surgery. Crit Care. 2016 Nov 15;20(1):370. doi: 10.1186/s13054-016-1536-6. PMID 27846908

+Investigators

Olav Rooyackers, PhDProfessor, Study chair, Karolinska University Hopsital

My Notes

Public

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