NCT02574156

Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperglycemia

Interventions

Type	Name	Description
DRUG	Insulin	All patients will receive insulin. However, the infusion flow will be different according to the group.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-08-01
• Completion: 2019-04-01
• First posted: 2015-10-12
• Last updated: 2022-11-04

Locations

1 site across 1 country: Brazil