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

Medical Centre Leeuwarden

Status and phase: Completed; Phase 3

Conditions: Septic Shock; Sepsis

Treatments: Drug: placebo = nacl 0.9%; Drug: nitroglycerin iv

Study type: Interventional

Funder types: Other

Identifiers

NCT00493415

CCMO NL12558.099.06

Eudract 2006-004298-88

TPO 436

ABR 12558

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

nitroglycerine iv

Treatment:

Drug: nitroglycerin iv

2

Placebo Comparator group

Description:

nacl 0.9% 4 ml/h iv in the first 30 minutes, 2 ml/h iv in the next 23 hours and 30 minutes

Treatment:

Drug: placebo = nacl 0.9%