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| Sponsored by: |
Medical Centre Leeuwarden |
|---|---|
| Information provided by: | Medical Centre Leeuwarden |
| ClinicalTrials.gov Identifier: | NCT00493415 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| 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 |
|---|---|
|
1: Experimental
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
|
|
2: Placebo Comparator
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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| Medical Centre Leeuwarden - Intensive Care Unit | |
| Leeuwarden, Netherlands, 8901 BR | |
| Principal Investigator: | E C Boerma, MD | Medical Centre Leeuwarden |
More Information
| Responsible Party: | Medical Center Leeuwarden ( EC Boerma ) |
| 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 |
| ClinicalTrials.gov Identifier: | NCT00493415 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
microcirculation sepsis nitroglycerine SDF imaging |
|
Nitroglycerin Systemic Inflammatory Response Syndrome Sepsis Shock |
Shock, Septic Congenital Abnormalities Inflammation |
|
Vasodilator Agents Pathologic Processes Therapeutic Uses |
Cardiovascular Agents Infection Pharmacologic Actions |
