NCT01049087

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 20, 2013

Status Verified

January 1, 2010

Enrollment Period

Same day

First QC Date

January 13, 2010

Last Update Submit

March 19, 2013

Conditions

Healthy

Keywords

plasma volumetechnetium-labeled albuminradioiodine-labeled albuminHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Plasma volume determined by 99mTc-labeled albumin and 125I-labeled albumin

    January 2011

Secondary Outcomes (1)

  • Rates of loss of 99mTc-labeled albumin and 125I-labeled albumin from the circulation

    January 2011

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \< 27 kg/m2
  • Written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Koge, Department of Clinical Physiology and Nuclear Medicine

Køge, DK-4600, Denmark

Location

MeSH Terms

Interventions

Plasma Volume

Intervention Hierarchy (Ancestors)

Blood VolumeBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaHemodynamicsCardiovascular Physiological Phenomena

Study Officials

  • Steen Levin, MD, DMSc

    Zealand University Hospital

    STUDY CHAIR

  • Peter K Bonfils, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

  • Knud H Stokholm, MD

    Zealand University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

January 1, 2012

Primary Completion

January 1, 2012

Study Completion

December 1, 2012

Last Updated

March 20, 2013

Record last verified: 2010-01

Locations

DK(1)