Clinical Trial: Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery

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

Official Title: Sitagliptin for the Prevention and Treatment of Hyperglycemia in Patients With Type 2 Diabetes Undergoing Cardiac Surgery

Brief Summary: The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is effective in maintaining blood sugar control in patients with type 2 diabetes (T2D).

Detailed Summary: The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) and the need for continuous intravenous insulin infusion (CII) in the intensive care unit (ICU) in patients with type 2 diabetes (T2D) undergoing coronary artery bypass graft (CABG) surgery. In addition, the study seeks to determine whether treatment with sitagliptin is effective in maintaining glycemic control and in preventing the need for subcutaneous (SC) insulin therapy in patients with T2D during the transition from intensive care unit (ICU) to regular floor in cardiac surgery patients with T2D.
Sponsor: Emory University

Current Primary Outcome:

• Frequency of hyperglycemia in the intensive care unit (ICU) [ Time Frame: 2 days (average time of discharge from ICU) ]
  The percent of patients with blood glucose (BG) levels greater than 160 mg/dl
• Number of patients with persistent hyperglycemia [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Number of patients with two consecutive fasting and/or pre-meal blood glucose (BG) greater than 180 mg/dl, or with average daily BG greater than 80 mg/dl who require rescue therapy with subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Rate of continuous intravenous insulin infusion (CII) for treatment of hyperglycemia [ Time Frame: 2 days (average time of discharge from ICU) ]
  Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl.
• Mean blood glucose (BG) concentration in the intensive care unit (ICU) [ Time Frame: 2 days (average time of discharge from ICU) ]
  Mean BG concentration of ICU patients during recovery period.
• Mean insulin dose per hour during intensive care unit (ICU) (ICU) recovery [ Time Frame: 2 days (average time of discharge from ICU) ]
  Mean insulin infusion dose per hour (unit/hour) of ICU patients during recovery period.
• Mean insulin dose per day during intensive care unit (ICU) recovery [ Time Frame: 2 days (average time of discharge from ICU) ]
  Mean insulin infusion dose per day of ICU patients during recovery period.
• Duration of continuous intravenous insulin infusion (CII) [ Time Frame: 2 days (average time of discharge from ICU) ]
  Total hours of continuous intravenous insulin infusion (CII)
• Number of patients requiring subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII) [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Total number of patients requiring subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII)
• Days of subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII) [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Total number of days patients requiring SC insulin after discontinuation of CII
• Mean non-intensive care unit (ICU) blood glucose (BG) concentration [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Mean BG concentration of non-ICU patients during recovery period.
• Amount of subcutaneous (SC) insulin taken in intensive care unit (ICU) [ Time Frame: 2 days (average time of discharge from ICU) ]
  Total amount of SC insulin taken by ICU patients during recovery period.
• Amount of subcutaneous (SC) insulin taken in non-intensive care unit (ICU) [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Total amount of SC insulin taken by non-intensive care unit (ICU) patients during recovery period.
• Rate of hyperglycemic events in intensive care unit (ICU) [ Time Frame: 2 days (average time of discharge from ICU) ]
  Number of hyperglycemic events (blood glucose greater than or equal to 200 mg/dL) in ICU patients during recovery period.
• Rate of hyperglycemic events in non-intensive care unit (ICU) [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Number of hyperglycemic events (blood glucose greater than or equal to 200 mg/dL) in non-ICU patients recovery period.
• Rate of hypoglycemic events in intensive care unit (ICU) [ Time Frame: 2 days (average time of discharge from ICU) ]
  Number of hypoglycemic events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU).
• Rate of hypoglycemic events in non-intensive care unit (ICU) [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Number of hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU).
• Rate of severe hypoglycemic events in intensive care unit (ICU) [ Time Frame: 2 days (average time of discharge from ICU) ]
  Number of severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU).
• Rate of severe hypoglycemic events in non-intensive care unit (ICU) [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Number of hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU).
• Composite of perioperative complications [ Time Frame: 10 days (average time of discharge from the hospital) ]
  Number of perioperative complications including hospital mortality,sternal wound infection, bacteremia, pneumonia, acute renal failure, and acute mycordial infarction.
• Duration of ventilary support [ Time Frame: 10 days (average time of discharge from the hospital) ]
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Emory University
  

  Dates:
  Date Received: September 21, 2015
  Date Started: January 2016
  Date Completion:
  Last Updated: July 29, 2016
  Last Verified: July 2016
  

  

  Join Millions

  Sign Up For One Of Our
  Newsletters

  Email

  Sign Up