Clinical trial NCT01115166: Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation
Official title: Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Volume, Extravasation
Keywords: blood volume
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients subjected to open cardiac surgery, with the help of extracorporal circulation.

Brief summary: In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is subjected to large changes. The purpose of this study is to see if it is possible with the help of volume kinetic techniques to use these variations to measure blood volume and fluid escape from the intravascular volume.

Detailed description: In many clinical situations, such as extensive surgery, it is of value to determine blood volume and rate of fluid loss from the intravascular space, since hypo- and hypervolemia are combined with increased morbidity and mortality. In this study we which to use the large variations in hemoglobin during extracorporal to calculate both these variables.

Hemoglobin is measured every 5 minutes during one hour beginning shortly before start of the heart-lung machine. When the extracorporal circulation begins the hemoglobin decreases due to the quick mix and dilution of the priming fluid from the heart-lung machine with the patients blood.

From the amount of priming fluid and the fall of the hemoglobin, the blood volume can be calculated. If no further fluid is given the next 20 to 30 minutes, the hemoglobin concentration will in most cases increase as a result of the fluid loss from the vascular space. This increase in combination with the diureses can be used to calculate the intravascular fluid loss to the interstitium during surgery.

Sodium concentration will also be measured in parallel with the hemoglobin concentration.

The Sodium concentrations in combination with given and excreted (urine)Sodium can be used in a mass balance to calculate if intracellular edema is induced.

Eligibility criteria: Inclusion Criteria:

* open heart surgery, with extracorporal circulation
* consent to participation

Primary outcomes:
measure: Blood Volume
timeFrame: 30 minutes after start of CPB
Secondary outcomes:
measure: Intracellular Edema
timeFrame: 30 minutes after CPB
Other outcomes:
measure: Fluid Extravasation
timeFrame: Two distribution half-times. Approximately 16 minutes.
Locations:
city: Linkoeping
country: Sweden
facility: University Hospital, Thoracic operation ward
Study officials:
affiliation: University Hospital, Linköping, Sweden
name: Joachim Zdolsek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tornudd M, Hahn RG, Zdolsek JH. Fluid distribution kinetics during cardiopulmonary bypass. Clinics (Sao Paulo). 2014 Aug;69(8):535-41. doi: 10.6061/clinics/2014(08)06.