The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis (NISMIS)
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|ClinicalTrials.gov Identifier: NCT00493415|
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : July 16, 2008
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|
|Sepsis Septic Shock||Drug: nitroglycerin iv Drug: placebo = nacl 0.9%||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||June 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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
- increase of MFI by nitro-glycerine [ Time Frame: 2 years ]
- decrease of length of stay decrease of SOFA decrease of morbidity/mortality [ Time Frame: 2 years ]
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
|Medical Centre Leeuwarden - Intensive Care Unit|
|Leeuwarden, Netherlands, 8901 BR|
|Principal Investigator:||E C Boerma, MD||Medical Centre Leeuwarden|