Clinical trial NCT01900769: Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study
Official title: Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Determine Validity of Concept of Using Hemoglobin Dilution to Assess/Measure Blood Volume.
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: matching BV by Hemoglobin dilution (lab)
timeFrame: 5 - 40 minutes
Secondary outcomes:
measure: matching BV by Hemoglobin dilution (SpHb)
timeFrame: 5 - 40 minutes
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Kai Schoenhage, MD
role: PRINCIPAL_INVESTIGATOR
References: