Trial Outcomes & Findings for Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation (NCT NCT01115166)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

30 minutes after start of CPB

Results posted on

2012-10-08

Participant Flow

January 2010 to September 2010 at thoracic surgery department

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

Participant milestones

Participant milestones
Measure	Cardiac Surgery Patients subjected to open cardiac surgery with the help of extracorporal circulation.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac Surgery n=10 Participants Patients subjected to open cardiac surgery with the help of extracorporal circulation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age Continuous	71.1 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment Sweden	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cardiac Surgery n=10 Participants Patients subjected to open cardiac surgery with the help of extracorporal circulation.
Blood Volume	4.61 Litre Standard Deviation 0.86

SECONDARY outcome

Timeframe: 30 minutes after CPB

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

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.

Outcome measures

Outcome measures
Measure	Cardiac Surgery n=10 Participants Patients subjected to open cardiac surgery with the help of extracorporal circulation.
Intracellular Edema	-0.33 Litre Standard Deviation 0.557

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cardiac Surgery n=10 Participants Patients subjected to open cardiac surgery with the help of extracorporal circulation.
Fluid Extravasation	0.38 mL/kg/min Standard Deviation 0.24

Adverse Events

Cardiac Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joachim Zdolsek

Department of Anaestesilogy and Intensive Care

Phone: +46101030000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place