Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Mean Blood Glucose of All Readings
研究概览
简要总结
The objective of this study is to determine the best insulin regimen for hospitalized patients who receive high doses of steroids who have high blood glucose.
详细描述
The overall study objective of this research is to establish the efficacy and assure the safety of achieving glycemic control in hospitalized patients who receive greater than physiologic doses of steroids. This study will compare 2 methods of achieving glycemic control in hospitalized patients who develop steroid-induced hyperglycemia (blood glucose (BG) >180 mg/dL): 1) a study-specific steroid NPH dosing algorithm plus standard recommended care (Experimental group) vs. 2) the standard recommended care (Methodist Hospital Complete Insulin Orders (Control group).
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
- •Men or women aged ≥18 years who receive steroids in doses greater than physiologic replacement levels of ≥ 10 mg Prednisone or its equivalent of dexamethasone or methylprednisolone.
- •Have signed the consent form for the study
- •Have a BG > 180 mg/dL any time during the first 24 hour of steroid administration that is above physiological replacement ( ≥ 10 mg Prednisone or equivalent)
- •Are scheduled to be in hospital ≥ 2 days.
排除标准
- •Unable to read or understand English
- •History of psychiatric disability affecting informed consent or compliance with drug intake
- •Type 1 diabetes
- •Acute or chronic renal failure (creatinine clearance < 30 mL/min estimated by method of Cockcroft and Gault)
- •Patients in Hospice Care
- •Age <18 years
- •Previously enrolled in this study.
- •Not appropriate for the steroid protocol in judgment of the principal investigator and/or attending physician.
研究组 & 干预措施
Experimental group
a study-specific steroid (NPH) dosing algorithm plus standard recommended care. The intervention is Neutral Protamine Hagedorn (NPH) insulin plus complete insulin orders (CIO).
干预措施: NPH insulin plus Complete Insulin Orders (Drug)
Control group
the standard recommended care (Methodist Hospital Complete Insulin Orders)
干预措施: Complete Insulin Orders (Drug)
结局指标
主要结局
Mean Blood Glucose of All Readings
时间窗: starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days
Starting 3 hours after the initial index blood glucose (BG) \>180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is \> 5 days
次要结局
未报告次要终点