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

NCT01686776 | Completed Phase 3 DMC

• 2 other identifiers: 3.00 # amended version 1.12012-002638-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

• 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

Keywords

Plasma albumine; Plasma volume; Transcapillary escape rate; Inflammation; Circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fractional catabolic rate (FCR)

  42 days

Other Outcomes (1)

• plasma albumin turnover rate

  42 days

Study Arms (3)

123 I-HSA + 125 I-HSA

ACTIVE COMPARATOR

Healthy Volunteers, N=16

Other: 123 I-HSA + 125 I HSA

123 I- HSA + 125 I-HSA

EXPERIMENTAL

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

Other: 123 I-HSA + 125 I HSA

123-I-HSA+125 I-HSA

EXPERIMENTAL

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

Other: 123 I-HSA + 125 I HSA

Interventions

123 I-HSA + 125 I HSA OTHER

Compare and validate the method of measuring albumine turnover rate

123 I- HSA + 125 I-HSA; 123 I-HSA + 125 I-HSA; 123-I-HSA+125 I-HSA

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ake Norberg: lead

Study Sites (1)

Karolinska University Hospital, Huddinge

Stockholm, SE-141 86, Sweden

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olav Rooyackers, PhDProfessor

  Karolinska University Hopsital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D, PhD

Model Details: 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

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: September 27, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

SE (1)