HealthyPhase 3NCT01686776
A Prospective Validation Study of Albumin Kinetics With Tracer 123 I-HSA
A Phase 3 study testing 123 I-HSA + 125 I HSA in people with Healthy and SIRS, run by Ake Norberg at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- What is being tested?
- 123 I-HSA + 125 I HSA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 27 Sep 2012to 1 Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery
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:
Read more
- 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?
- Being tested
- 123 I-HSA + 125 I HSA
- Keywords
- Plasma albumine, Plasma volume, Transcapillary escape rate, Inflammation, Circulation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
123 I-HSA + 125 I HSAOther
Compare and validate the method of measuring albumine turnover rate
| Study group | Role | What they receive |
|---|---|---|
| 123 I-HSA + 125 I-HSA | Active comparator | Healthy Volunteers, N=16 Receives: Other: 123 I-HSA + 125 I HSA |
| 123 I- HSA + 125 I-HSA | Experimental | Patients, planned for elective Major Abdominal Surgery, N=16 Receives: Other: 123 I-HSA + 125 I HSA |
| 123-I-HSA+125 I-HSA | Experimental | Patients, with a acute pancreatitis or cholecystitis, N=16 Receives: Other: 123 I-HSA + 125 I HSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)?
Measured: 42 days
Secondary outcomes (1)
Fractional catabolic rate (FCR)
Non compartmental analysis (NCA) and AUC (time-conc) will be determine the pharmacokinetics like clearance, distribution volume and absolute catabolic rate
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study start27 Sep 2012
- Primary completion1 Jun 2013
- Study completion1 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ake Norberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ake Norberg, Karolinska Institutet
- Investigators
- Olav Rooyackers, PhDProfessor, Study chair, Karolinska University Hopsital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686776
- Sponsor's protocol ID
- 3.00 # amended version 1.1
- Other IDs
- 2012-002638-35
- Status last verified
- Feb 2018
- First submitted
- 13 Sep 2012
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27846908
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Validation Study in Healthy Volunteers, Patients With Acute Inflammation and Patients Scheduled for Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01686776
- Acronym / sponsor ID
- 3.00 # amended version 1.1
- Keywords
- Plasma albumine, Plasma volume, Transcapillary escape rate, Inflammation, Circulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ake NorbergUniversity, hospital or other
- Study start
- 27 Sep 2012 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Jun 2013 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 123 I-HSA + 125 I-HSA | Active comparator | Other: 123 I-HSA + 125 I HSAHealthy Volunteers, N=16 |
| 123 I- HSA + 125 I-HSA | Experimental | Other: 123 I-HSA + 125 I HSAPatients, planned for elective Major Abdominal Surgery, N=16 |
| 123-I-HSA+125 I-HSA | Experimental | Other: 123 I-HSA + 125 I HSAPatients, with a acute pancreatitis or cholecystitis, N=16 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 123 I-HSA + 125 I HSACompare and validate the method of measuring albumine turnover rate | Other | 123 I- HSA + 125 I-HSA, 123 I-HSA + 125 I-HSA, 123-I-HSA+125 I-HSA |
Primary outcome
Transcapillary Escape Rate (TER)of Albumin
Time frame: 42 days
Is the measured value for 123-I-HSA and 125I-HSA identical/equal regarded TER and plasma volume (PV)?
1 secondary outcome
Fractional catabolic rate (FCR)
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Results publication: PubMed 27846908Komaromi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav Rooyackers, PhDProfessor study chair
Karolinska University Hopsital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 123 I-HSA + 125 I HSA in people with Healthy and SIRS, run by Ake Norberg at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcapillary Escape Rate (TER)of Albumin (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01686776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.