Clinical trial NCT02443402: Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery
Official title: Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Non diabetic hyperglycemia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.

Detailed description: About 80% of patients develop high glucose after cardiac surgery. High glucose is linked to an increased risk of hospital complications. High glucose increases the risk of wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. This study will determine if sitagliptin can prevent the development of high glucose after heart surgery. Sitagliptin is a diabetes pill approved by the Food and Drug Administration (FDA) to treat patients with diabetes.

Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
* No previous history of diabetes
* No previous history of hyperglycemia

Exclusion Criteria:

* Patients with hyperglycemia (blood glucose \> 125 mg/dL); or glycated hemoglobin (HbA1c) \> 6.5%; or previous treatment with oral antidiabetic agents or insulin
* Severely impaired renal function (serum creatinine ≥3.0 mg/dL or GFR \< 30 mL/min) or clinically significant hepatic failure
* Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
* Subjects with gastrointestinal (GI) obstruction or adynamic ileus or those expected to require GI suction
* Patients with clinically relevant pancreatic or gallbladder disease
* Treatment with oral or injectable corticosteroid
* Mental condition rendering the subject unable to understand the scope, and consequences of the study
* Female subjects who are pregnant or breast feeding at time of enrollment into the study

Primary outcomes:
measure: Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
timeFrame: Post-Surgery (Up to 4 Days)
measure: Number of Subjects With Persistent Hyperglycemia
timeFrame: Post-Surgery (Up to 10 Days)
Secondary outcomes:
measure: Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
timeFrame: Post-Surgery (Up to 4 Days)
measure: Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
timeFrame: Post-Surgery (Up to 4 Days)
measure: Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
timeFrame: Post-Surgery (Up to 4 Days)
measure: Duration of Continuous Intravenous Insulin (CII)
timeFrame: Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)
measure: Mean Units Subcutaneous (SQ) Insulin Required
timeFrame: Post-Surgery (Up to 10 Days)
measure: Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)
timeFrame: Post-Surgery (Up to 4 Days)
measure: Total Insulin Therapy in the Intensive Care Unit (ICU)
timeFrame: Post-Surgery (Up to 4 Days)
measure: Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
timeFrame: Post-Surgery (Up to 4 Days)
measure: Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
timeFrame: Post-Surgery (Up to 10 Days)
measure: Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
timeFrame: Post-Surgery (Up to 4 Days)
measure: Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
timeFrame: Post-Surgery (Up to 4 Days)
measure: Number of Participants With Blood Glucose Less Than 40 mg/dl
timeFrame: Duration of Hospitalization (Up to 30 Days)
measure: Hospital Mortality Rate
timeFrame: Post-Surgery (Up to 10 Days)
measure: Intensive Care Unit (ICU) Mortality Rate
timeFrame: Post-Surgery (Up to 4 Days)
measure: Number of Participants With Cerebrovascular Events
timeFrame: Post-Hospital Discharge (Up to 10 Days)
measure: Hospital Complication Rate
timeFrame: Duration of Hospitalization (Up to 30 days)
measure: Length of Stay: Intensive Care Unit (ICU)
timeFrame: Post-Surgery (Up to 4 Days)
measure: Length of Hospital Stay After Study Randomization
timeFrame: Post-Randomization (Up to 9 days)
measure: Number of Participants Re-admitted to the Hospital Due to Wound Infections
timeFrame: Post-Hospital Discharge (Up to 30 Days)
measure: Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
timeFrame: Post-Hospital Discharge (Up to 30 Days)
measure: Number of Participants With Emergency Room (ER) Visits
timeFrame: Post-Hospital Discharge (Up to 30 Days)
measure: Number of Participants With Infections Not Requiring Hospital Re-admission
timeFrame: Post-Hospital Discharge (Up to 30 Days)
measure: Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
timeFrame: Post-Surgery (Up to 2 Days)
measure: Number of Subjects Requiring Re-intubation
timeFrame: Post-Surgery (Up to 2 Days)
measure: Number of Subjects Requiring Re-intubation Within 24 Hours
timeFrame: Post-Surgery (Up to 24 Hours)
measure: Number of Subject Requiring Surgical Re-Intervention
timeFrame: Post-Surgery (Up to 10 Days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital - Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: