NCT01115166|CompletedResults
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Sponsor study identifier
observational
10
1 country
1
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
May 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
May 3, 2010
Actual (reported)May 4, 2010
Actual (reported)October 2010
Actual (reported)May 2012
Actual (reported)October 8, 2012
Actual (reported)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. 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.
30 minutes after start of CPB
Intracellular Edema
30 minutes after CPB
Fluid Extravasation
Two distribution half-times. Approximately 16 minutes.
Patients subjected to open cardiac surgery with the help of extracorporal circulation.
Patients subjected to open cardiac surgery, with the help of extracorporal circulation.
University Hospital, Thoracic operation ward
Linköping, Linkoeping, 581 85, Sweden
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.
The number of patients was small and it was not possible to use a reference method. Standardization was difficult due to the fact that it was a clinical study.
Joachim Zdolsek, MD, PhD
University Hospital, Linköping, Sweden
10 participants (actual enrollment reported by the registry).
First Submitted
May 3, 2010
First Posted
May 4, 2010
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2010
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
October 8, 2012
Results First Posted
October 8, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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