Complications Clinical Trial
Official title:
Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion and Improving Outcomes in Patients Undergoing CABG. A Prospective Randomized Trial
A total of 80 patients will be randomly allocated into 2 groups, group A and placebo group using concealed envelope method.Group A patients (n= 40)will receive single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. Patients in the placebo group (n=40) will receive as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.
A total of 80 patients will randomly allocated into 2 groups, group A and placebo group using
concealed envelope method.Group A patients (n= 40) will receive single dose intravenous
infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg.
Patients in the placebo group (n=40) will receive as a single-dose of saline (Natriumklorid 9
mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.
General anesthesia will the institutional standards and all surgeries will be performed by
the same surgical team.Standardized monitoring will be applied.After median sternotomy,CPB
will be established with 1500 ml crystalloid priming volume and mild hypothermia (32°C) with
a Trillium Affinity oxygenator (Medtronic,Minneapolis, Minnesota, USA) and a Sarns CPB
machine (Harrison, Mt. Clemens, Michigan, USA) at a flow rate of 2.6 lmin−1m−2.Myocardial
protection will be done using cold blood cardioplegia at 20°C. During CPB, homologous donor
packed red blood cells will be transfused if hemoglobin was less than 6.5 gdl−1.During
bypass, anticoagulation for extracorporeal circulation was performed using heparin 300 U/kg
administered into the right atrium. Acelite activated clotting time (ACT) greater than 400
was considered adequate for commencing CPB; if less, an additional dose of 100Uof heparin
will be adminstered.CPB will be conducted using nonocclusive roller pumps, arterial line
filtration ,membrane oxygenators, , and blood-enriched cold hyperkalemic arrest. Systemic
hypothermia documented by an esophageal temperature of 32°C will be maintained during aortic
cross clamping.After completion of CPB and removal of the arterial cannula, heparin will be
neutralized with 1 mg of protamine sulfate adminstered for every 100U of heparin over a
period of 15 minutes . Eventually, a second dose of protamine 50 mg will be given if ACT
remained above baseline. All patients will be transferred to ICU after surgery.
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