Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Completed

• Conditions: Blood Volume, Extravasation

• Registration Number: NCT01115166
• Lead Sponsor: University Hospital, Linkoeping

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2010-10
• Study Completion: 2012-05
• Results First Submitted: 2012-05-11
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-06
• Last Update Submitted: 2012-09-06
• Results First Posted: 2012-10-08
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Volume	30 minutes after start of CPB	volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.; 1. 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.; 2. 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.

Secondary Outcome Measures

Name	Time	Method
Intracellular Edema	30 minutes after CPB	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.

Trial Locations

Locations (1)

University Hospital, Thoracic operation ward; 🇸🇪 Linkoeping, Sweden