- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01115166
Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Linkoeping, Sweden, 581 85
- University Hospital, Thoracic operation ward
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- open heart surgery, with extracorporal circulation
- consent to participation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Cardiac surgery
Patients subjected to open cardiac surgery with the help of extracorporal circulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Volume
Time Frame: 30 minutes after start of CPB
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volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intracellular Edema
Time Frame: 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. |
30 minutes after CPB
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fluid Extravasation
Time Frame: Two distribution half-times. Approximately 16 minutes.
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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.
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Two distribution half-times. Approximately 16 minutes.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joachim Zdolsek, MD, PhD, University Hospital, Linköping, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BVECC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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