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临床试验/NCT00812253
NCT00812253已完成2 期

Intensive Glycemic Control for Congestive Heart Failure Exacerbation

Kathleen Dungan1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Hospital Length of Stay

研究概览

简要总结

Patients with heart failure often have high blood sugar (glucose).

详细描述

Patients with heart failure often have high blood sugar. High glucose contributes to severe hospital complications and even death. Studies suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. In this study, we will determine whether normalizing blood sugars using intravenous insulin short-term will improve outcomes in patients hospitalized for congestive heart failure. We enrolled patients with severe heart failure and randomly assigned them into 2 groups. We used intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2. We determined whether intravenous insulin improved hospital length of stay, rates of readmission, inflammatory markers, and cardiovascular 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

入选标准

  • Age 18 and above
  • Admitted (less than 48 hours) to the OSU Ross Heart Hospital 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

Active Comparator

Basal bolus insulin (4 injections per day)

干预措施: Subcutaneous insulin (Drug)

Intravenous Insulin

Experimental

干预措施: Intravenous insulin (Drug)

结局指标

主要结局

Hospital Length of Stay

时间窗: Days

Duration of hospitalization in days

次要结局

  • Hospital Readmission(30 days)
  • Change in Quality of Life(30 day)
  • Brain Natriuretic Peptide (BNP)(72 hours)
  • Heart Rate Variability(72 hours)
  • Cardiac Output(72 hours)

研究者

发起方
Kathleen Dungan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kathleen Dungan

Assistant Professor

Ohio State University

研究点 (1)

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