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Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01115166
Enrollment
10
Registered
2010-05-04
Start date
2010-05-31
Completion date
2012-05-31
Last updated
2012-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Volume, Extravasation

Keywords

blood volume

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.

Interventions

None listed

Sponsors

University Hospital, Linkoeping
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Volume30 minutes after start of CPBvolume 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

MeasureTime frameDescription
Intracellular Edema30 minutes after CPBMass 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.

Other

MeasureTime frameDescription
Fluid ExtravasationTwo distribution half-times. Approximately 16 minutes.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.

Countries

Sweden

Participant flow

Recruitment details

January 2010 to September 2010 at thoracic surgery department

Pre-assignment details

Included patients (10). All participated in the study.

Participants by arm

ArmCount
Cardiac Surgery
Patients subjected to open cardiac surgery with the help of extracorporal circulation.
10
Total10

Baseline characteristics

CharacteristicCardiac Surgery
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
8 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
Age Continuous71.1 years
STANDARD_DEVIATION 11.6
Region of Enrollment
Sweden
10 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

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. 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.

Time frame: 30 minutes after start of CPB

Population: The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.

ArmMeasureValue (MEAN)Dispersion
Cardiac SurgeryBlood Volume4.61 LitreStandard Deviation 0.86
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.

Time frame: 30 minutes after CPB

Population: Mainly observational. 10 patients were regarded to be a sufficient number to se a tendency.

ArmMeasureValue (MEAN)Dispersion
Cardiac SurgeryIntracellular Edema-0.33 LitreStandard Deviation 0.557
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.

Time frame: Two distribution half-times. Approximately 16 minutes.

Population: The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.

ArmMeasureValue (MEDIAN)Dispersion
Cardiac SurgeryFluid Extravasation0.38 mL/kg/minStandard Deviation 0.24

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026