Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin
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Purpose
The purpose of the present study is to compare plasma volume determination by 99mTc-labeled albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that plasma volume determined by the different methods are the same.
| Condition | Intervention |
|---|---|
|
Healthy |
Radiation: Plasma volume determination (99mTc-albumin) Radiation: Plasma volume determination (125I-albumin) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin |
- Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
- Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation [ Time Frame: January 2011 ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | January 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
-
Radiation: Plasma volume determination (99mTc-albumin)
For many years, radioiodinated albumin has been "the golden standard" for measurement of plasma volume. There are a number of clinical situations in which a nuclide with a shorter half-life would be preferred. Furthermore, due to periodic lapses in the availability in the delivery of 125I-labeled albumin, there is a need to evaluate another nuclide as a tracer for plasma volume determination.
99mTc-labeled albumin is easily prepared by a simple and reproducible method with a high labeling efficiency and short half-life.
In this study, we want to compare plasma volume determined by 99mTc-labeled albumin with plasma volume determined by 125I-albumin (golden standard). In both procedures, plasma volume is estimated from multiple postinjection samples for accurate zero-time extrapolation in order to correct for leakage of labeled albumin from the vascular compartment.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI < 27 kg/m2
- Written informed consent
Exclusion Criteria:
- Hypertension (140/90 mmHg)
- Diabetes mellitus
- Any use of medication
- Pregnancy
Contacts and Locations| Denmark | |
| University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine | |
| Koge, Denmark, DK-4600 | |
| Study Chair: | Steen Levin, MD, DMSc | University Hospital Koge |
| Principal Investigator: | Peter K Bonfils, MD | University Hospital Koge |
| Study Director: | Knud H Stokholm, MD | University Hospital Koge |
More Information
No publications provided
| Responsible Party: | Peter Kramshoj Bonfils, University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine |
| ClinicalTrials.gov Identifier: | NCT01049087 History of Changes |
| Other Study ID Numbers: | SJ-112 |
| Study First Received: | January 13, 2010 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Roskilde County Hospital:
|
plasma volume technetium-labeled albumin radioiodine-labeled albumin Healthy volunteers |
ClinicalTrials.gov processed this record on June 19, 2013