Glycemic Control and Variability for Congestive Heart Failure Exacerbation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Hospital Readmission
研究概览
简要总结
High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.
详细描述
High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •Admitted (less than 48 hours) to the with worsening heart failure
- •Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c >6.5%.
排除标准
- •Type 1 diabetes
- •Receiving comfort care measures only
- •Hospital stay expected to be less than 2 days
- •Pregnancy
- •Prisoners
- •Participation in the study on prior hospitalizations
- •Acute myocardial infarction within 3 months
- •End stage renal or liver disease
研究组 & 干预措施
Subcutaneous Insulin
4 injections of insulin/day
干预措施: Subcutaneous insulin (Drug)
Intravenous insulin
干预措施: Intravenous insulin (Drug)
结局指标
主要结局
Hospital Readmission
时间窗: 30 days
All-cause hospital readmission within 30 days
Hospital Length of Stay
时间窗: participants were followed for the duration of hospital stay, median hospital stay 8 day
Duration of hospitalization
次要结局
- High Frequency Heart Rate Variability(24 hours)
- Pre-ejection Period (PEP)(24 hours)
- Coefficient of Variation (CV)(24 hours)
- High Sensitivity C-reactive Protein (Hs-CRP)(72 hours)
- Quality of Life(30 days)
- Mean Glucose(24 hours)
- Brain Natriuretic Peptide (BNP)(72 hours)
- Glycemic Lability Index (GLI)(24 hours)
研究者
Kathleen Dungan
Assistant Professor
Ohio State University