Hyperglycemia
Conditions
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.
Interventions
DRUGInsulin
All patients will receive insulin. However, the infusion flow will be different according to the group.
Sponsors
InCor Heart Institute
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing heart surgery; * Age greater than 18 years; * Sign the informed consent form; * Capillary blood glucose greater than 200mg/dL ICU admission
Exclusion criteria
* Admitted for surgical repair of congenital heart defects; * Dialytic Chronic renal failure; * Participation in other research protocol; * Diagnosis of HIV/AIDS; * Pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection of surgical wound infection | 30 days | The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Need for reoperation | 30 days | This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines |
| Need for transfusion of blood products | 90 days | — |
| Occurrences of hypoglycemia | 90 days | — |
| Prolonged mechanical ventilation | 90 days | — |
Countries
Brazil
Outcome results
None listed