Clinical Trial: Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

Brief Summary: The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.

Detailed Summary:

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.


Sponsor: University of Sao Paulo

Current Primary Outcome: Infection of surgical wound infection [ Time Frame: 30 days ]

The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines


Original Primary Outcome: Death from any cause [ Time Frame: 90 days ]

Current Secondary Outcome:

  • Need for reoperation [ Time Frame: 30 days ]
    This outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines
  • Acute renal injury (defined by the KDIGO classification) [ Time Frame: 30 days ]
    This outcome measure will be assessed according to the KDIGO Criterion
  • Infection of the bloodstream [ Time Frame: 90 days ]
  • Prolonged mechanical ventilation [ Time Frame: 90 days ]
  • Need for transfusion of blood products [ Time Frame: 90 days ]
  • Occurrences of hypoglycemia [ Time Frame: 90 days ]


Original Secondary Outcome:

  • Need for reoperation [ Time Frame: 90 days ]
  • Acute renal injury (defined by the KDIGO classification) [ Time Frame: 90 days ]
  • Infection of the bloodstream [ Time Frame: 90 days ]
  • Infection of surgical wound infection [ Time Frame: 90 days ]
  • Prolonged mechanical ventilation [ Time Frame: 90 days ]
  • Need for transfusion of blood products [ Time Frame: 90 days ]
  • Occurrences of hypoglycemia [ Time Frame: 90 days ]


Information By: University of Sao Paulo

Dates:
Date Received: October 8, 2015
Date Started: January 1, 2017
Date Completion: December 20, 2018
Last Updated: May 5, 2017
Last Verified: May 2017