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Study aim
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Determining level of serum urea, creatinine, liver enzymes, consciousness level, arterial blood gases and cerebral oxygenation before ,during and after surgery in patients undergoing open heart surgery, separating two groups of normal flow and high flow
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Design
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A randomized, controlled, phase 3 clinical trial on 60 patients.
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Settings and conduct
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The preparation conditions before and during the operation will be completely the same for the patients of both groups. Such as the amount and composition of the solutions used for priming, the same oxygenators, the same method of induction and maintenance of anesthesia, and also during the establishment of the cardiopulmonary pump, mild hypothermia will be used in both groups of patients. During the entire study, in order to avoid bias, one surgeon and one perfusionist will be present in all operations.
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Participants/Inclusion and exclusion criteria
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Entry criteria include: Candidate for open heart surgery;
Non-entry criteria include: Patients with congestive heart failure or cardiac EF below 30%; Patients who need an intra-aortic balloon pump; Duration of aortic clamp more than 2 hours and surgery more than 3 hours; Patients with a history of stroke, any disorder of level of consciousness before the operation; Patients with chronic renal failure or undergoing hemodialysis; The occurrence of any unpredictable conditions and malfunction of the pump during surgery;
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Intervention groups
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Normal flow :a flow rate of 2.4 liters per square meter per minute is used, which is the usual flow rate used during open heart surgery.
High flow: a flow rate of 2.6 liters per square meter per minute is used.
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Main outcome variables
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The aim of study is investigating the effect of high flow cardiopulmonary pump on the level of urea creatinine, Liver enzymes, consciousness, brain tissue oxygenation , serum electrolyte, lactate in patients undergoing surgery.