Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Infection of surgical wound infection
研究概览
简要总结
The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.
详细描述
Patients undergoing heart surgery at the Heart Institute (InCor) will be randomized and in accordance with a list of random numbers, generated by a computer program, are allocated in one of the treatment groups (conventional or intensive) when the blood glucose value recorded is greater than 200 mg/dl on two consecutive measures in an interval of 30 minutes.Conventional Group (GCon): patients randomized to the conventional group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.
Group intensive (GInt): patients randomized to the intensive group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 90 mg/dl and 110 mg/dl.
The insulin dose adjustment will be based on measurements of arterial blood glucose undiluted, held at intervals of one to 4 hours with the use of a monitoring system of glucose and beta-blood ketone (Freestyle Precision Pro, Abbott). The dosage is adjusted according to an algorithm by a team of intensive care nurses, trained for this purpose and assisted by a study physician not involved in the clinical care of patients.
On admission, all patients will receive intravenous glucose solution continuously (200 to 300 g in 24 hours). As soon as possible, the patient will be nurtured according to the routine of Surgical ICU for nutrition in the postoperative period of cardiac surgery patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing heart surgery;
- •Age greater than 18 years;
- •Sign the informed consent form;
- •Capillary blood glucose greater than 200mg/dL ICU admission
排除标准
- •Admitted for surgical repair of congenital heart defects;
- •Dialytic Chronic renal failure;
- •Participation in other research protocol;
- •Diagnosis of HIV/AIDS;
- •Pregnant.
研究组 & 干预措施
Conventional Group
Patients randomized for Conventional Group will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.
干预措施: Insulin (Drug)
Moderate Group
Patients randomized for ModerateGroup will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 100 mg/dl and 130 mg/dl.
干预措施: Insulin (Drug)
结局指标
主要结局
Infection of surgical wound infection
时间窗: 30 days
The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
次要结局
- Need for transfusion of blood products(90 days)
- Occurrences of hypoglycemia(90 days)
- Acute renal injury (defined by the KDIGO classification)(30 days)
- Infection of the bloodstream(90 days)
- Prolonged mechanical ventilation(90 days)
- Need for reoperation(30 days)
研究者
Eduesley Santana Santos
RN, Ph.D
University of Sao Paulo