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IRCT2017012932276N1 IRCT 2017-06-27 iran univercity of medical science The effect of regulating the flow rate of cardiopulmonary bypass pump based on lean body mass index on mixed venous blood oxygen and arterial blood lactat level among patients with abnormal range of body mass index The effect of regulating the flow rate of cardiopulmonary bypass pump based on lean body mass index on mixed venous blood oxygen and arterial blood lactat level among patients with abnormal range of body mass index 2017-05-19 anticipated 152 Complete https://irct.ir/trial/25181 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Allocation of samples in the form of blocks Random can be done using a computer. 2-3 Heart disease. Intervention 1: In this study, in the intervention group, patients with BMI over 25, obtained number from lean body mass will be multiplied by 2.4 and according to it pump flow will be arranged in cardiopulmonary bypass machine. After anesthesia, first blood sample will be taken using 2 ml heparinized syringe from radial artery and the venous blood sample will be taken from the central venous. Second blood sample will be obtained after cross- clamped of the aorta and cardioplegia induction. During rewarming and after declamping in temperature between 35-37 degree, third sample will be taken from oxygenator arterial line sample and venous reservoir entrance, respectively. In case of long surgery procedures, sampling will be repeated every half an hour. Finally, based on gained samples, measuring arterial lactate level and mixed venous oxygen saturation will be done. Intervention 2: In this study, in the control group, patients with BMI over 25, obtained number from bodr sueface area will be multiplied by 2.4 and according to it pump flow will be arranged in cardiopulmonary bypass machine. After anesthesia, first blood sample will be taken using 2 ml heparinized syringe from radial artery and the venous blood sample will be taken from the central venous. Second blood sample will be obtained after cross- clamped of the aorta and cardioplegia induction. During rewarming and after declamping in temperature between 35-37 degree, third sample will be taken from oxygenator arterial line sample and venous reservoir entrance, respectively. In case of long surgery procedures, sampling will be repeated every half an hour. Finally, based on gained samples, measuring arterial lactate level and mixed venous oxygen saturation will be done.
public Parvin Vahid
School of Nursing, Iran University of Medical Sciences, Rashid Yaasemi street, Valiasr street
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2886 vahid .p@tak.iums.ac.ir Iran University of Medical Science scientific dr Tahereh Najafi Ghezeljeh
School of Nursing, Iran University of Medical Sciences, Rasheed Yaasemi street, Valiasr street
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2885 najafi.t@iums.ac.ir School of nursing & midwifery of Iran University of Medical Science Iran (Islamic Republic of) Inclusion criteria: 1، Older than 18 years old 2، body mass index of between 25-35 3،open heart surgery with the use of cardiopulmonary bypass 4،not having disorder in kidney, lung, liver and cerebral and treatment-resistant hypertension 5, left ventricular ejection fraction more than 30% 6، patients with bilateral carotid artery stenosis greater than 50% or unilateral carotid stenosis greater than 70% 7,patients elective open heart surgery exclusion criteria from the study: 1 , any event that affect the normal process of open heart surgery include cardiopulmonary bypass requirement though surgery, persistent decline of blood pressure through cardiopulmonary bypass that not respond to Inotropic drug 2, death 3, aortic clamping time over 100 minutes 4, temperature reduction below 28 degree during operation for any reason the surgeon decide to catch a lower temperature than 28 degree 18 years 70 years Both I25.0 Atherosclerotic cardiovascular disease, so described Prevention Treatment - Drugs In this study, in the intervention group, patients with BMI over 25, obtained number from lean body mass will be multiplied by 2.4 and according to it pump flow will be arranged in cardiopulmonary bypass machine. After anesthesia, first blood sample will be taken using 2 ml heparinized syringe from radial artery and the venous blood sample will be taken from the central venous. Second blood sample will be obtained after cross- clamped of the aorta and cardioplegia induction. During rewarming and after declamping in temperature between 35-37 degree, third sample will be taken from oxygenator arterial line sample and venous reservoir entrance, respectively. In case of long surgery procedures, sampling will be repeated every half an hour. Finally, based on gained samples, measuring arterial lactate level and mixed venous oxygen saturation will be done. In this study, in the control group, patients with BMI over 25, obtained number from bodr sueface area will be multiplied by 2.4 and according to it pump flow will be arranged in cardiopulmonary bypass machine. After anesthesia, first blood sample will be taken using 2 ml heparinized syringe from radial artery and the venous blood sample will be taken from the central venous. Second blood sample will be obtained after cross- clamped of the aorta and cardioplegia induction. During rewarming and after declamping in temperature between 35-37 degree, third sample will be taken from oxygenator arterial line sample and venous reservoir entrance, respectively. In case of long surgery procedures, sampling will be repeated every half an hour. Finally, based on gained samples, measuring arterial lactate level and mixed venous oxygen saturation will be done On mixed venous oxygen saturation. Timepoint: after anesthesia,during cardiiopulmonary bypass,after cardiopulmonary bypass. Method of measurement: content of each gas in arterial blood Under the pressure of eac gas. Arterial blood lactate. Timepoint: after anesthesia,during cardiiopulmonary bypass,after cardiopulmonary bypass. Method of measurement: arterial blood sample. O2 consumption. Timepoint: during cardiopulmonary bypass. Method of measurement: content of each gas in venous blood Under the pressure of eac gas and pump flow rate. iran univercity of medical science Approved 2017-03-04 Ethics Committee of Iran Univercity of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat highway, Tehran, Iran Tehran Iran (Islamic Republic of)