Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin

NCT01049087 — Not applicable, Completed, 15 participants, Zealand University Hospital

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Comparison of Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin

RegistryNCT01049087
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, single group, masking: single, basic science
Enrollment15 (Actual)
SponsorZealand University Hospital (Other)
ConditionsHealthy
InterventionsPlasma volume determination (99mTc-albumin), Plasma volume determination (125I-albumin) (Radiation)
Datesstart 2012-01-01, primary completion 2012-01-01, completion 2012-12-01, first posted 2010-01-14, last updated 2013-03-20
Locations1 site in Denmark

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of Plasma volume determination (99mTc-albumin) All trials of Plasma volume determination (125I-albumin)

-Summary

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.

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+Detailed description

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.

+Arms and interventions

  • Plasma volume determination (99mTc-albumin) (Radiation): The test is performed using 5MBq technetium-labeled albumin (99mTc-albumin-Vasculosis) with several postinjection samples for accurate zero-time extrapolation.
  • Plasma volume determination (125I-albumin) (Radiation): The test is performed using 0.2MBq 125iodine-labeled albumin (125I-albumin) with several postinjection samples for accurate zero-time extrapolation.

+Outcome measures

Primary outcomes

  • Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin [January 2011]

Secondary outcomes

  • Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation [January 2011]

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria:

* BMI < 27 kg/m2
* Written informed consent

Exclusion Criteria:

* Hypertension (140/90 mmHg)
* Diabetes mellitus
* Any use of medication
* Pregnancy

+Locations (1)

FacilityCityCountryStatus
University Hospital Koge, Department of Clinical Physiology and Nuclear MedicineKøgeDenmark

+Investigators