Completed

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

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What is being tested

123 I-HSA + 125 I HSA

+ 123 I-HSA + 125 I HSA

+ 123 I-HSA + 125 I HSA

Other
Who is being recruted

Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

+ Inflammation

Over 40 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 3
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorAke Norberg
Last updated: February 19, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: September 27, 2012

Actual date on which the first participant was enrolled.

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. 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? 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?

NCT01686776
Principal SponsorAke Norberg
Last updated: February 19, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsInflammation

Criteria

6 inclusion criteria required to participate
healthy volunteers (treatment arm I)
on contraceptive agent and/or contraceptive device
patients with a acute pancreatitis or cholecystitis (treatment arm III)
planned for elective larger interabdominal surgery (treatment arm II)
Show More Criteria
4 exclusion criteria prevent from participating
allergy towards excipients in 123 I HSA or 125 I HSA
it is the opinion of the principle investigator that the patient/subject should not participate for his/hers own good
participates in another study involving radiation or stabile isotopes within a period of 60 days to study start
pregnant women and/or lactating

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Healthy Volunteers, N=16

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Karolinska University Hospital, Huddinge

Stockholm, SwedenOpen Karolinska University Hospital, Huddinge in Google Maps
CompletedOne Study Center