Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Blood Volume, Extravasation Clinical Trial

Official title:

Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115166
• Other study ID #: BVECC
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: September 6, 2012
• Start date: May 2010
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• open heart surgery, with extracorporal circulation

• consent to participation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Volume, Extravasation

Locations

Country	Name	City	State
Sweden	University Hospital, Thoracic operation ward	Linkoeping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fluid Extravasation	Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.	Two distribution half-times. Approximately 16 minutes.	No
Primary	Blood Volume	volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.; The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.; The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.; To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated.	30 minutes after start of CPB	No
Secondary	Intracellular Edema	Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.; A positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass.	30 minutes after CPB	No