Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
研究概览
简要总结
The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
- •No previous history of diabetes
- •No previous history of hyperglycemia
排除标准
- •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
研究组 & 干预措施
Sitagliptin
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Sitagliptin (Drug)
Sitagliptin
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Regular Human Insulin (Drug)
Sitagliptin
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Insulin glargine (Drug)
Sitagliptin
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Supplemental insulin (Insulin lispro) (Drug)
Sitagliptin
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Supplemental insulin (Insulin aspart) (Drug)
Placebo
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Placebo (Drug)
Placebo
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Regular Human Insulin (Drug)
Placebo
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Insulin glargine (Drug)
Placebo
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Supplemental insulin (Insulin lispro) (Drug)
Placebo
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
干预措施: Supplemental insulin (Insulin aspart) (Drug)
结局指标
主要结局
Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
时间窗: Post-Surgery (Up to 4 Days)
Number of participants who developed stress hyperglycemia (BG \>180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.
Number of Subjects With Persistent Hyperglycemia
时间窗: Post-Surgery (Up to 10 Days)
Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG \> 180 mg/dL, or with average daily BG \>180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)
次要结局
- Hospital Complication Rate(Duration of Hospitalization (Up to 30 days))
- Length of Hospital Stay After Study Randomization(Post-Randomization (Up to 9 days))
- Duration of Continuous Intravenous Insulin (CII)(Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days))
- Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)(Post-Surgery (Up to 4 Days))
- Number of Participants With Cerebrovascular Events(Post-Hospital Discharge (Up to 10 Days))
- Length of Stay: Intensive Care Unit (ICU)(Post-Surgery (Up to 4 Days))
- Mean Units Subcutaneous (SQ) Insulin Required(Post-Surgery (Up to 10 Days))
- Intensive Care Unit (ICU) Mortality Rate(Post-Surgery (Up to 4 Days))
- Hospital Mortality Rate(Post-Surgery (Up to 10 Days))
- Total Insulin Therapy in the Intensive Care Unit (ICU)(Post-Surgery (Up to 4 Days))
- Number of Participants Re-admitted to the Hospital Due to Wound Infections(Post-Hospital Discharge (Up to 30 Days))
- Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)(Post-Surgery (Up to 4 Days))
- Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)(Post-Surgery (Up to 4 Days))
- Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)(Post-Surgery (Up to 10 Days))
- Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay(Post-Surgery (Up to 4 Days))
- Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)(Post-Surgery (Up to 4 Days))
- Number of Participants With Blood Glucose Less Than 40 mg/dl(Duration of Hospitalization (Up to 30 Days))
- Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia(Post-Surgery (Up to 4 Days))
- Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration(Post-Surgery (Up to 4 Days))
- Number of Participants Re-admitted to the Hospital Not Due to Wound Infections(Post-Hospital Discharge (Up to 30 Days))
- Number of Subjects Requiring Re-intubation(Post-Surgery (Up to 2 Days))
- Number of Participants With Infections Not Requiring Hospital Re-admission(Post-Hospital Discharge (Up to 30 Days))
- Number of Participants With Emergency Room (ER) Visits(Post-Hospital Discharge (Up to 30 Days))
- Number of Subject Requiring Surgical Re-Intervention(Post-Surgery (Up to 10 Days))
- Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours(Post-Surgery (Up to 2 Days))
- Number of Subjects Requiring Re-intubation Within 24 Hours(Post-Surgery (Up to 24 Hours))
研究者
Guillermo Umpierrez
Professor
Emory University