Condition 1: Coronary artery disease. Condition 2: Coronary artery bypass graft. Atherosclerotic heart disease Mechanical complication of coronary artery bypass and valve grafts
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: patients with coronary artery disease, scheduled for elective, first time on-pump CABG. Exclusion criteria: Redo CABG patients; Off pump CABG patients; patients with previous history of taking drugs affecting hemostasis such as warfarin, or patients with deranged hemostatic tests preoperatively.Exceptionally, patients on plavix will be included, provided the drug withheld at least five days before operation; patients with concomitant procedures in addition to CABG, such as mitral valve replacement or repair and so on.These procedures may enhance complexity and duration of surgery, affecting outcomes; patients with unexpected and undesirable complications during operation, for instance aortic rupture following cannulation, in whom outcomes may be altered.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of postoperative hemorrhage. Timepoint: 24 hours after operation. Method of measurement: Ratio quantitative variable, through observation of the quantity of bleeding draining from chest tubes connected to patient in cubic centimeter(cc).;Need to reexploration due to bleeding. Timepoint: Within 24 hours of operation. Method of measurement: Nominal qualitative variable,indicating need to reexploration to control bleeding.;Rate of hospital mortality. Timepoint: Within the period of hospitalization(about one week or more in terms of length of hospital stay). Method of measurement: Nominal qualitative variable, indicating the presence or absence of death during hospitalization period.;Rate of postoperative myocardial infarction(postop MI). Timepoint: Within one month of operation. Method of measurement: Nominal qualitative variable, indicating the presence or absence of postop MI in terms of clinical,electrocardiographic and echocardiographic criteria.;Rate of postoperative stroke. Timepoint: Within the period of hospitalization(about one week or more in terms of length of hospital stay). Method of measurement: Nominal qualitative variable, indicating the presence or absence of postoperative stroke in terms of clinical and imaging criteria within the period of hospitalization.;The length of ICU stay. Timepoint: at the time of discharge from ICU. Method of measurement: Ratio quantitative variable in days.;The length of hospital stay. Timepoint: At the time of discharge from hospital. Method of measurement: Ratio quantitative variable in days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Need to inotrope during weaning. Timepoint: At the time of weaning. Method of measurement: Ordinal qualitative variable, indicating need to inotropes during weaning and if needed categorizing as low,moderate and high dose.;Need to postoperative intraaortic balloon pump(IABP). Timepoint: During the period of hospitalization. Method of measurement: Nominal qualitative variable, indicating the need to IABP during hospitalization.;Rate of postoperative renal failure. Timepoint: During the period of hospitalization, daily measurement of Cr at ICU and then at least once on the floor. Method of measurement: Nominal qualitative variable, indicating the presence or absence of Cr>1.5 during the period of hospitalization.;Rate of postoperative arrythmia. Timepoint: During the period of hospitalization. Method of measurement: Nominal qualitative variable, indicating the presence or absence of postop arrythmia including atrial fibrillation during the period of hospitalization.;Rate of postoperative pericardial effusion and tamponade. Timepoint: During the period of hospitalization. Method of measurement: Ordinal qualitative variable, indicating the presence or absence of postoperative pericardial effusion, ranging from mild pericardial effusion requiring no treatment to tamponade necessitating execution of surgical pericardial window.;Rate of postoperative cardiac related readmission. Timepoint: During the follow-up period. Method of measurement: Nominal qualitative variable, indicating the need to readmission after discharge due to cardiac reasons during the follow-up period.;Follow-up period. Timepoint: Since discharge until the end of study(at most one year). Method of measurement: Intervening and ratio continuous quantitative variable, indicating follow-up period after operation mainly to determine the need for readmission due to cardiac problems, described in months.;Postoperative ejection fraction of left ventricle(postop LVEF). Timepoint: At least once after operation du | — |
Countries
Iran (Islamic Republic of)
Contacts
Arak University of Medical Sciences