The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis
Information source: Medical Centre Leeuwarden
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sepsis; Septic Shock
Intervention: nitroglycerin iv (Drug); placebo = nacl 0.9% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Medical Centre Leeuwarden Official(s) and/or principal investigator(s): E C Boerma, MD, Principal Investigator, Affiliation: Medical Centre Leeuwarden
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).
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: increase of MFI by nitro-glycerine
Secondary outcome: decrease of length of stay decrease of SOFA decrease of morbidity/mortality
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Medical Centre Leeuwarden - Intensive Care Unit, Leeuwarden 8901 BR, Netherlands
Additional Information
Starting date: June 2007
Last updated: July 15, 2008
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