Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study

February 17, 2014 updated by: Kai Schoenhage

Although blood volume is such an important parameter in everyday clinical medicine it cannot be measured easily. As a matter of fact, it is almost never measured but estimated or calculated based upon numbers derived from mostly healthy patients.

The investigators do not even know whether someone's normal - i.e. before a surgery - blood volume is actually anywhere close to the generally accepted estimate or calculation.

Tests exist in which a substance of known concentration is diluted in a person's blood volume and the resulting concentration is then measured, which allows the blood volume to be calculated. However, none of these tests can be completed at the bedside since they are not fast and require considerable set-up.

This study turns the above approach upside-down: we will dilute the blood slightly with a known small volume of an intravenous fluid commonly used in many clinical settings and measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells - before and after adding the fluid. That allows for similar calculations without using neither specialized substances nor equipment.

Hemoglobin is routinely measured in laboratories and is often a routine test before and during surg-eries and in intensive care units.

Devices that can measure hemoglobin through the skin without actually drawing any blood are avail-able. If found comparable to laboratory determination of hemoglobin they could provide for a bedside and almost real-time assessment of blood volume, something that could be extremely valuable for de-cision making in critical areas of medicine and promoting goal directed therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adults of normal constitution (weight/height)

Exclusion Criteria:

  • any ongoing or recent infusions (< 24h ago) of any fluid/substance
  • morbid obesity
  • heart disease
  • hypertension
  • coagulopathy (bleeding disorder)
  • therapy with anti- or procoagulants
  • transfusion of any blood product
  • therapy with diuretics
  • therapy with vasopressors
  • vasodilators or inotropes
  • acute or chronic infections
  • immunocompromised status
  • hemodynamically unstable
  • hemorrhage (bleeding)
  • recent surgery
  • pregnancy
  • younger than 18 years old

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood Volume Dilution
Drug: Blood Volume Dilution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
matching BV by Hemoglobin dilution (lab)
Time Frame: 5 - 40 minutes
5 - 40 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
matching BV by Hemoglobin dilution (SpHb)
Time Frame: 5 - 40 minutes
5 - 40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kai Schoenhage

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 13-0077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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