The Effect of Nitroglycerine on Microcirculatory Abnormalities During Sepsis (NISMIS)
|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|
|Primary Completion Date :||July 2008|
|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 ]
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|