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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iron therapy group | Active Comparator | Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. |
|
| placebo | Placebo Comparator | Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside 1000 | Drug | Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| haemoglobin concentration change | the change in the Hb concentration at baseline, intraoperative, at discharge and 1 week after discharge in non-anaemic patients undergoing cardiac surgery. | 1 week after discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| hospital stay | duration of hospital stay | 7 to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Shoeb, professor | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university | Cairo | 11566 | Egypt |
study protocol statistical analysis data analysis
6 months
Descriptive statistics will be carried out for numerical parametric data and presented as mean±SD, whereas categorical data will be presented as number and percentage. Variables such as demographic data and comorbidities will be compared using the χ2-test
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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| placebo | Other | Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min. |
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