Sepsis, Septic Shock
Conditions
Keywords
microcirculation, sepsis, nitroglycerine, SDF imaging
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.
Interventions
DRUGnitroglycerin iv
loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes
DRUGplacebo = nacl 0.9%
4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes
Sponsors
Frisius Medisch Centrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increase of MFI by nitro-glycerine | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| decrease of length of stay decrease of SOFA decrease of morbidity/mortality | 2 years |
Countries
Netherlands
Outcome results
None listed