Clincosm LogoSign in Get a demo

NISMIS: The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis

Sponsor
Medical Centre Leeuwarden (Other)
Overall Status
Completed
CT.gov ID
NCT00493415
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
13
Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: nitroglycerin iv
  • Drug: placebo = nacl 0.9%
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
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
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • isotonic saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. increase of MFI by nitro-glycerine [2 years]

    Secondary Outcome Measures

    1. decrease of length of stay decrease of SOFA decrease of morbidity/mortality [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00493415
    Other Study ID Numbers:
    • TPO 436
    • ABR 12558
    • Eudract 2006-004298-88
    • CCMO NL12558.099.06
    First Posted:
    Jun 28, 2007
    Last Update Posted:
    Jul 16, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    microcirculation
    sepsis
    nitroglycerine
    SDF imaging
    Additional relevant MeSH terms:
    Sepsis
    Nitroglycerin

    Study Results

    No Results Posted as of Jul 16, 2008