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IRCT2016101130266N1 IRCT 2017-08-26 Vice Chancellor Of Research, Iran University of Medical Sciences Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery 2016-12-21 anticipated 70 Complete https://irct.ir/trial/24109 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: This study is randomized controlled clinical trial with blocked randomization. 2-3 Valvular heart disease. Intervention 1: During open heart surgery when patient is on cardiopulmonary bypass after aortic cross clamping and cardioplegic arrest patients undergoing pulsatile perfusion. pulsatile features on heart lung machine set as following: frequency: 70 beat per minute, pulse width: 50%, base flow: 30%( 70%pulsatile and 30% nonpulsatile). Intervention 2: In control group during cardiopulmonary bypass after aortic cross clamping patients undergoing routine(non pulsatile) perfusion.
public Samira Moosaei Far
School of Nursing & Midwifery, Shahid Rashid Yasemi Street, Valiasr Street, Tehran
Tehran Iran (Islamic Republic of) +98 919 165 0136 samira.moosaei@gmail.commosaeifar.s@tak.iums.ac.ir Iran University of Medical Sciences scientific Tahereh Najafi Ghezeljeh
School of Nursing & Midwifery, Shahid Rashid Yasemi Street, Valiasr Street,Tehran
Tehran Iran (Islamic Republic of) +98 21 4365 1000 najafi.t@iums.ac.ir School of Nursing & Midwifery of Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients with valvular heart disease that needs surgical replacement or repair of heart valves, body surface area less than 2, Age 18 to 65, Estimated cardiopulmonary bypass time greater than 60 minute, Left ventricle ejection fraction(LVEF) 40% and greater than 40% Exclusion criteria: patients with carotid stenosis, atherosclerosis of ascending aorta and aortic arch, history of cerebrovascular accident, diabetic patient, hepatic disorders, alcoholism, patients needs emergency or complicated and redo surgeries, congenital heart disease, pregnancy, patients disagreement(without consent), preoperation arterial lactate levels greater than 2 miliigram per deciliter, arteial blood gases not in normal rang during cardiopulmonary bypass, patients who needs intraaortic baloon pump(IABP), extracorporeal membrane oxygenation(ECMO) or patients with open sternum, cardiac arrest 18 years 65 years Both I134,I135, Nonrheumatic mitral valve disorders, Nonrheumatic aortic valve disorders, Nonrheumatic tricuspid valve disorders, Pulmonary valve disorders Other Other During open heart surgery when patient is on cardiopulmonary bypass after aortic cross clamping and cardioplegic arrest patients undergoing pulsatile perfusion. pulsatile features on heart lung machine set as following: frequency: 70 beat per minute, pulse width: 50%, base flow: 30%( 70%pulsatile and 30% nonpulsatile) In control group during cardiopulmonary bypass after aortic cross clamping patients undergoing routine(non pulsatile) perfusion. Arterial blood lactate level. Timepoint: after anasthasia and mechanical ventilation, after aortic cross clamping, after aortic cross clamp removal, termination of cardiopulmonary bypass, 2 and 4 hours post operation room. Method of measurement: arterial blood sample ( our lab reference unit is milligram per decilitre). Cerebral oxygenetion. Timepoint: During the whole time of surgery and cardiopulmonary bypass. Method of measurement: To evaluate cerebral oxygenetion we use INVOS cerebral /somatic oxymeter, the values are measured continuously as a percentage of oxygen saturation. Liver enzymes(AST& ALT). Timepoint: Pre & Post operation. Method of measurement: blood sample(our lab reference unit is Unit per liter). Renal function tests( BUN & Cr). Timepoint: Pre & Post operation. Method of measurement: blood sample(our lab reference unit is milligram per deciliter). Lactate dehydrogenase(LDH). Timepoint: Pre & Post operation. Method of measurement: blood sample( our lab reference unit is Unit per liter). Platelet count. Timepoint: Pre & Post operation. Method of measurement: blood sample(our lab reference unit is platelete count per microliters). Urine out put. Timepoint: Pre CPB, Pre aortic cross clamp, after removal of aortic cross clamp, termination of CPB. Method of measurement: Through direct vision urine volume(in millilite)r is measured by collecting in urine bag. Vice Chancellor Of Research, Iran University of Medical Sciences Approved 2016-11-21 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat highway, Tehran Tehran Iran (Islamic Republic of)