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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00493415
First Posted: June 28, 2007
Last Update Posted: July 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical Centre Leeuwarden
  Purpose

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).


Condition Intervention Phase
Sepsis Septic Shock Drug: nitroglycerin iv Drug: placebo = nacl 0.9% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • increase of MFI by nitro-glycerine [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • decrease of length of stay decrease of SOFA decrease of morbidity/mortality [ Time Frame: 2 years ]

Enrollment: 70
Study Start Date: June 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
nitroglycerine iv
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
Other Name: nitropohl
Placebo Comparator: 2
nacl 0.9% 4 ml/h iv in the first 30 minutes, 2 ml/h iv in the next 23 hours and 30 minutes
Drug: 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
Other Name: isotonic saline

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493415


Locations
Netherlands
Medical Centre Leeuwarden - Intensive Care Unit
Leeuwarden, Netherlands, 8901 BR
Sponsors and Collaborators
Medical Centre Leeuwarden
Investigators
Principal Investigator: E C Boerma, MD Medical Centre Leeuwarden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EC Boerma, Medical Center Leeuwarden
ClinicalTrials.gov Identifier: NCT00493415     History of Changes
Other Study ID Numbers: TPO 436
ABR 12558
Eudract 2006-004298-88
CCMO NL12558.099.06
First Submitted: June 27, 2007
First Posted: June 28, 2007
Last Update Posted: July 16, 2008
Last Verified: July 2008

Keywords provided by Medical Centre Leeuwarden:
microcirculation
sepsis
nitroglycerine
SDF imaging

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Nitroglycerin
Vasodilator Agents