Evaluation the effect of pulsatile perfusion during cardiopulmonary bypass on cerebral tissue oxygenation and arterial blood lactate leveles in patients undergoing valvular heart Surgery

Phase 2

• Conditions: Valvular heart disease.; Nonrheumatic mitral valve disorders, Nonrheumatic aortic valve disorders, Nonrheumatic tricuspid valve disorders, Pulmonary valve disorders; I134,I135,

• Registration Number: IRCT2016101130266N1
• Lead Sponsor: Vice Chancellor Of Research, Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
iver 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.