The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis (NISMIS)

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).

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.

• Sepsis
• Septic Shock

• Drug: nitroglycerin iv
  loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes
  Other Name: nitropohl
• Drug: placebo = nacl 0.9%
  4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes
  Other Name: isotonic saline

• Experimental: 1
  nitroglycerine iv
  Intervention: Drug: nitroglycerin iv
• Placebo Comparator: 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
  Intervention: Drug: placebo = nacl 0.9%

Inclusion Criteria:

• Severe sepsis
• Proven infection
• Informed consent

Exclusion Criteria:

• Age < 18 years
• Pregnancy
• Use of nitroglycerine within 24 hours prior to ICU admittance
• Necessity to use nitroglycerine iv for instable angina