The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis
- Conditions
- SepsisSeptic Shock
- Interventions
- Drug: placebo = nacl 0.9%
- Registration Number
- NCT00493415
- Lead Sponsor
- Medical Centre Leeuwarden
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Severe sepsis
- Proven infection
- Informed consent
- Age < 18 years
- Pregnancy
- Use of nitroglycerine within 24 hours prior to ICU admittance
- Necessity to use nitroglycerine iv for instable angina
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 nitroglycerin iv nitroglycerine iv 2 placebo = nacl 0.9% nacl 0.9% 4 ml/h iv in the first 30 minutes, 2 ml/h iv in the next 23 hours and 30 minutes
- Primary Outcome Measures
Name Time Method increase of MFI by nitro-glycerine 2 years
- Secondary Outcome Measures
Name Time Method decrease of length of stay decrease of SOFA decrease of morbidity/mortality 2 years
Trial Locations
- Locations (1)
Medical Centre Leeuwarden - Intensive Care Unit
🇳🇱Leeuwarden, Netherlands