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

This study has been completed.
Sponsor:
Information provided by:
Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT00493415
First received: June 27, 2007
Last updated: July 15, 2008
Last verified: July 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • increase of MFI by nitro-glycerine [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • decrease of length of stay decrease of SOFA decrease of morbidity/mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Medical Centre Leeuwarden

Additional 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
Study First Received: June 27, 2007
Last Updated: July 15, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013