Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of new infections
研究概览
简要总结
RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.
PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
Primary
- To determine whether intensive glycemic control over an eight week time period will decrease the incidence of infections from initiation of chemotherapy treatment in patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Secondary
- To compare the number of episodes of infection.
- To compare the duration of neutropenia.
- To compare the number of days of bacteremia/fungemia.
- To compare the number of days of fever.
- To compare the duration of nutrition.
- To compare the duration of mucositis.
- To compare the duration of hospital stay.
- To compare the duration of antibiotic use.
- To compare the incidence of thromboembolic events.
- To compare body weight changes.
- To compare the median survival.
- To compare the remission rate with induction or salvage chemotherapy.
- To conduct comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients with goal blood glucose 80-14 mg/dL receive the Robert Wood Johnson Hospital IV insulin infusion protocol followed by insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks.
干预措施: insulin glargine recombinant (Biological)
Arm I
Patients with goal blood glucose 80-14 mg/dL receive the Robert Wood Johnson Hospital IV insulin infusion protocol followed by insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks.
干预措施: therapeutic insulin (Drug)
Arm II
Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale.
干预措施: insulin glargine recombinant (Biological)
Arm II
Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale.
干预措施: therapeutic insulin (Drug)
结局指标
主要结局
Incidence of new infections
时间窗: 4 years
次要结局
- Number of episodes of infection(4 years)
- Duration of neutropenia(4 years)
- Number of days of bacteremia/fungemia(4 years)
- Number of days of fever(4 years)
- Duration of nutrition(4 years)
- Duration of mucositis(4 years)
- Duration of hospital stay(4 years)
- Duration of antibiotic use(4 years)
- Incidence of thromboembolic events(4 years)
- Body weight changes(4 years)
- Median survival(4 years)
- Remission rate with induction or salvage chemotherapy(4 years)
- Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring(4 years)