Rapid Administration of Insulin in Sepsis: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Absolute safety endpoint (explicit definitions)
研究概览
简要总结
The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can be safely administered to patients with septic shock. GIK has been used in thousands of critically ill patients in research studies with very few safety concerns. However, there is a lack of data in regards to patients with septic shock. There are many reasons to believe that GIK would be beneficial in sepsis, including improving heart function and decreasing inflammation. This study will administer intravenous GIK for 12 hours continuously and monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive the same monitoring but will not receive GIK.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed infection;
- •Any two of four criteria of systemic inflammatory response:
- •Temperature > 100.4° or < 96.8° F
- •Heart rate > 90 beats/minute
- •Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg
- •WBC >12,000 or < 4000 cells/µL or > 10% bands
- •Initiation of quantitative resuscitation protocol in the ED;
- •Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock
排除标准
- •Age <18 years;
- •Any primary diagnosis other than sepsis;
- •Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
- •Known hyperkalemia (serum potassium >5.5);
- •Dialysis-dependent renal failure;
- •Anticipated requirement for immediate surgery (within 24 hours);
- •Active participation in another interventional study;
- •Transferred from another hospital setting with sepsis therapy initiated;
- •Inability to obtain informed consent;
- •Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
- •Active malignancy currently under treatment (chemo- or radiation therapy);
- •Known systemic allergy to insulin;
- •History of periodic paralysis associated with carbohydrate loading;
- •Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).
研究组 & 干预措施
1
Glucose-insulin-potassium
干预措施: GIK (Drug)
结局指标
主要结局
Absolute safety endpoint (explicit definitions)
时间窗: During infusion
Change in SOFA score, microcirculatory flow
时间窗: During infusion
次要结局
未报告次要终点