Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
- Conditions
- Hyperglycemia
- Interventions
- Drug: Insulin
- Registration Number
- NCT02574156
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 500
- Patients undergoing heart surgery;
- Age greater than 18 years;
- Sign the informed consent form;
- Capillary blood glucose greater than 200mg/dL ICU admission
- Admitted for surgical repair of congenital heart defects;
- Dialytic Chronic renal failure;
- Participation in other research protocol;
- Diagnosis of HIV/AIDS;
- Pregnant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Group Insulin 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. Moderate Group Insulin 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.
- Primary Outcome Measures
Name Time Method Infection of surgical wound infection 30 days The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
- Secondary Outcome Measures
Name Time Method Need for transfusion of blood products 90 days Occurrences of hypoglycemia 90 days Acute renal injury (defined by the KDIGO classification) 30 days This outcome measure will be assessed according to the KDIGO Criterion
Infection of the bloodstream 90 days Prolonged mechanical ventilation 90 days Need for reoperation 30 days This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
Trial Locations
- Locations (1)
Eduesley Santana Santos
🇧🇷São Paulo, Brazil