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| ID | Type | Description | Link |
|---|---|---|---|
| ABR 12558 | |||
| Eudract 2006-004298-88 | |||
| CCMO NL12558.099.06 |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | nitroglycerine iv |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nitroglycerin iv | Drug | loading dose of 4mg/h iv in the first 30 minutes, 2 mg/h iv in the next 23 hours and 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| increase of MFI by nitro-glycerine | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| decrease of length of stay decrease of SOFA decrease of morbidity/mortality | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E C Boerma, MD | Frisius Medisch Centrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Centre Leeuwarden - Intensive Care Unit | Leeuwarden | 8901 BR | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19730258 | Derived | Boerma EC, Koopmans M, Konijn A, Kaiferova K, Bakker AJ, van Roon EN, Buter H, Bruins N, Egbers PH, Gerritsen RT, Koetsier PM, Kingma WP, Kuiper MA, Ince C. Effects of nitroglycerin on sublingual microcirculatory blood flow in patients with severe sepsis/septic shock after a strict resuscitation protocol: a double-blind randomized placebo controlled trial. Crit Care Med. 2010 Jan;38(1):93-100. doi: 10.1097/CCM.0b013e3181b02fc1. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| placebo = nacl 0.9% | Drug | 4 ml/h iv in the first 30 minutes, 2 ml /h iv in the next 23 hours and 30 minutes |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D017670 |
| Sodium Compounds |