Prospective Study Aim to Determine the Efficacy and Safety of a Glargine-based Hospital Discharge Algorithm in Cardiac Surgery Patients With Perioperative Hyperglycemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 3
- 主要终点
- Efficacy, Measured by a Change in HbA1c Levels
研究概览
简要总结
Most coronary artery bypass graft surgery (CABG) patients develop high blood sugar while they are in the hospital. No studies have shown what the best insulin regimen is for CABG patients with type 2 diabetes is after going home from the hospital. Patients with high blood sugar and diabetes after cardiac bypass surgery will be followed for 3 months to look at how well their treatment(s) for diabetes work after discharge. Patients with diabetes will be discharged on oral antidiabetic drugs or with insulin glargine injections based on their sugar control. Patients with admission HbA1c < 7% (a laboratory value that shows the average blood sugar level in the body over 3 months) will be discharged on the same diabetes medications that they used before coming to the hospital. Those with an HbA1c between 7% and 9% will be discharged on insulin glargine at 50%-80% of the dose used in the hospital and oral antidiabetic drugs. Those with an HbA1c > 9% will be discharged on glargine at 80-100% of the dose used in the hospital in addition to oral antidiabetic drugs or with insulin glargine and insulin glulisine. The primary outcome will be a change in HbA1c at 4 and 12 weeks after discharge.
详细描述
Hospital discharge represents a critical time for ensuring a safe transition to the outpatient setting and reducing the need for emergency department visits and re-hospitalization. Poor coordination of patient care and education on insulin administration at the time of patient discharge to home may be associated with medical errors that may increase risk of hypoglycemia, hyperglycemia and hospital readmission. No prospective studies have examined the impact of a discharge treatment regimen after cardiac surgery. Therefore, this study aims to determine the efficacy and safety of an HbA1c based treatment algorithm in controlling blood glucose (BG) after discharge. The total duration of the study is 3 months.
This study will include diabetic and non-diabetic subjects who participated in the American Diabetes Association (ADA) trial entitled "Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery." The ADA study is a two-arm randomized multicenter, open-label controlled trial aimed to determine if intensive insulin control with a BG target of 100-140mg/dl will reduce perioperative complications compared to a conventional BG control with a target of 141-180 mg/dl in hyperglycemic subjects who undergo coronary artery bypass graft surgery (CABG).
Treatment recommendations at discharge:
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Patients with admission HbA1c < 7%:
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Patients without a history of diabetes not requiring subcutaneous (SC) insulin in the hospital will be discharged on no antidiabetic therapy.
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Patients without a history of diabetes requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy. A patient without a history of diabetes who requires SC insulin is likely a newly diagnosed diabetic. The HbA1c value will be important to confirm the diagnosis. If the HbA1c is >6.5%, he/she will be diagnosed with diabetes. We do not anticipate that a patient without a history of diabetes and with an HbA1c <6.5% will require insulin treatment or oral agents long-term. Those patients will be discharged on no anti diabetic therapy with repeated testing after discharge to rule out diabetes.
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Patients with a history of diabetes will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).
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Assure there are no contraindications to oral agents (i.e.Thiazolidinediones (TZDs) and heart failure; metformin and renal failure or heart failure).
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Patients with Admission HbA1c between 7% and 9%:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 primary coronary artery bypass graft surgery (CABG).
- •Post surgical hyperglycemia (Blood glucose >140 mg/dl)
- •Patients with and without a history of type 2 diabetes
排除标准
- •Patients with severely impaired renal function (serum creatinine ≥3.0 mg/dl or a glomerular filtration rate < 30 ml/min) or clinically significant hepatic failure.
- •Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic states.
- •Moribund patients and those at imminent risk of death (brain death or cardiac standstill).
- •Patients or next-to-kin with mental conditions rendering the subject or family member unable to understand the nature, scope, and possible 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
Diabetic/ Metformin and 50-Glargine HbA1c 7%- 9%
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of total daily hospital dose.
干预措施: Metformin (Drug)
Diabetic/ Metformin and 50-Glargine HbA1c 7%- 9%
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of total daily hospital dose.
干预措施: Glargine insulin (Drug)
Diabetic/ Metformin and 80-Glargine HbA1c 7%-9%%
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c 7%- 9% will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of total daily hospital dose or with basal bolus regimen at same inpatient total daily insulin dose.
干预措施: Metformin (Drug)
Diabetic/ Metformin and 80-Glargine HbA1c 7%-9%%
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c 7%- 9% will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of total daily hospital dose or with basal bolus regimen at same inpatient total daily insulin dose.
干预措施: Glargine insulin (Drug)
No diabetes/ Metformin only
Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.
干预措施: Metformin (Drug)
Diabetic/antidiabetic regimen
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen. Subjects will receive one of the three treatment options based on their blood glucose levels: Metformin alone, both metformin and glargine insulin or glargine alone.
干预措施: Metformin (Drug)
Diabetic/antidiabetic regimen
Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen. Subjects will receive one of the three treatment options based on their blood glucose levels: Metformin alone, both metformin and glargine insulin or glargine alone.
干预措施: Glargine insulin (Drug)
No diabetes/ Insulin only
Subjects requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c <7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital.
干预措施: Glargine insulin (Drug)
Diabetes/Insulin only
Subjects requiring coronary artery bypass graft surgery (CABG) with an admission HbA1c >9% and persistent hyperglycemia will be given basal insulin (glargine) once daily, at the same time of the day and rapid-acting insulin (glulisine) before meals.
干预措施: Glargine insulin (Drug)
Diabetes/Insulin only
Subjects requiring coronary artery bypass graft surgery (CABG) with an admission HbA1c >9% and persistent hyperglycemia will be given basal insulin (glargine) once daily, at the same time of the day and rapid-acting insulin (glulisine) before meals.
干预措施: Glulisine (Drug)
结局指标
主要结局
Efficacy, Measured by a Change in HbA1c Levels
时间窗: One month after hospital discharge
Change in the level of HbA1c in a one month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.
次要结局
- The Number of Participants Experiencing a Hypoglycemic Event(3 months after discharge)
- The Number of Participants Experiencing a Severe Hypoglycemic Event(3 months after discharge)
- Number of Participants Readmitted to the Hospital(3 months after discharge)
- Number of Participants Experiencing a Hyperglycemic Event(3 months after discharge)
研究者
Guillermo Umpierrez, MD
Professor
Emory University