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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac surgery | Patients subjected to open cardiac surgery with the help of extracorporal circulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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.
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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Patients subjected to open cardiac surgery, with the help of extracorporal circulation.
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Zdolsek, MD, PhD | University Hospital, Linköping, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Thoracic operation ward | Linköping | Linkoeping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25141112 | Derived | 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. |
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Included patients (10). All participated in the study.
January 2010 to September 2010 at thoracic surgery department
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Surgery | Patients subjected to open cardiac surgery with the help of extracorporal circulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Surgery | Patients subjected to open cardiac surgery with the help of extracorporal circulation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
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. | The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes. | Posted | Mean | Standard Deviation | Litre | 30 minutes after start of CPB |
|
Patients were followed up to 24 hours after CPB. No intervention except additional blood samples was performed, during the CPB.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Surgery | Patients subjected to open cardiac surgery with the help of extracorporal circulation. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim Zdolsek | Department of Anaestesilogy and Intensive Care | +46101030000 | joachim.zdolsek@lio.se |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cardiac Surgery |
Patients subjected to open cardiac surgery with the help of extracorporal circulation. |
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| 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. | Mainly observational. 10 patients were regarded to be a sufficient number to se a tendency. | Posted | Mean | Standard Deviation | Litre | 30 minutes after CPB |
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| Other Pre-specified | 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. | The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes. | Posted | Median | Standard Deviation | mL/kg/min | Two distribution half-times. Approximately 16 minutes. |
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| 0 |
| 10 |
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| 10 |
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