NCT00493415

The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

The Evaluation of the Effect of Nitroglycerine Versus Placebo on the Microcirculation by Means of SDF Imaging in Septic Patients on the ICU

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Frisius Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Septic Shock

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-06-28
• Last updated: 2008-07-16

Locations

1 site across 1 country: Netherlands