Clinical trial NCT02574156: Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
Official title: Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hyperglycemia
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2015-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Infection of surgical wound infection
timeFrame: 30 days
Secondary outcomes:
measure: Need for reoperation
timeFrame: 30 days
measure: Acute renal injury (defined by the KDIGO classification)
timeFrame: 30 days
measure: Infection of the bloodstream
timeFrame: 90 days
measure: Prolonged mechanical ventilation
timeFrame: 90 days
measure: Need for transfusion of blood products
timeFrame: 90 days
measure: Occurrences of hypoglycemia
timeFrame: 90 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Eduesley Santana Santos
Study officials:
affiliation: University of Sao Paulo
name: Eduesley Santana Santos, Ph.D
role: PRINCIPAL_INVESTIGATOR
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