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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


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.


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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