The Evaluation of the Effect of Nitroglycerine Versus Placebo on the Microcirculation by Means of SDF Imaging in Septic Patients on the ICU
概览
- 阶段
- 3 期
- 干预措施
- nitroglycerin iv
- 疾病 / 适应症
- Sepsis
- 发起方
- Medical Centre Leeuwarden
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- increase of MFI by nitro-glycerine
- 状态
- 已完成
- 最后更新
- 17年前
概览
简要总结
The purpose of this study is to evaluate the effect of nitro-glycerine on the microcirculation (smallest vessel type) in patients with severe sepsis and septic shock.
Nitro-glycerine is a well known medicine in cardiology and is used to improve circulation. In this ICU the investigators use nitro-glycerine to improve the organ perfusion; but it's no common therapy in the rest of the world. The investigators now compare nitro-glycerine and placebo by looking to the sublingual microcirculation by a small camera (SDF imaging).
详细描述
This study starts at admission of the patient on the ICU. In the next 24 hours the patient receives nitro-glycerine or placebo (randomised). At time = 0, ½, 2, 12 and 24 hour we evaluate the microcirculation by SDF imaging and monitoring of hemodynamic parameters. Informed consent is obtained of the relatives.
研究者
入排标准
入选标准
- •Severe sepsis
- •Proven infection
- •Informed consent
排除标准
- •Age \< 18 years
- •Pregnancy
- •Use of nitroglycerine within 24 hours prior to ICU admittance
- •Necessity to use nitroglycerine iv for instable angina
研究组 & 干预措施
1
nitroglycerine iv
干预措施: nitroglycerin iv
2
nacl 0.9% 4 ml/h iv in the first 30 minutes, 2 ml/h iv in the next 23 hours and 30 minutes
干预措施: placebo = nacl 0.9%
结局指标
主要结局
increase of MFI by nitro-glycerine
时间窗: 2 years
次要结局
- decrease of length of stay decrease of SOFA decrease of morbidity/mortality(2 years)