The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

Sepsis Clinical Trial

— NISMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493415
• Other study ID #: TPO 436
• Secondary ID: ABR 12558Eudract
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2007
• Last updated: July 15, 2008
• Start date: June 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2008
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden - Intensive Care Unit	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase of MFI by nitro-glycerine		2 years	No
Secondary	decrease of length of stay decrease of SOFA decrease of morbidity/mortality		2 years	No