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The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy
Despite continued improvements in medical therapy, mortality from septic shock has remained between 30% and 70% for the past three decades with only a slight decrease in mortality rate. Standard treatment of septic shock is fluid resuscitation, followed by agents with vasopressor activity to correct hypotension in septic shock. The question rises whether vasopressors should be the first line of action in septic shock Opening and recruiting the microcirculation are expected to improve regional organ function and tissue distress in severe sepsis. Beside fluid resuscitation, vasodilatation, in this respect, enhances microcirculatory flow while vasoconstriction causes a reduction in microcirculatory flow. On the other hand, a minimal perfusion pressure should be present. Our aim is to asses the effects of two resuscitation protocols in severe sepsis: the "standard treatment" using predefined pressure goals versus a microcirculation guided therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dopamine | Drug | |||
| dobutamine | Drug | |||
| enoximone | Drug | |||
| nitroglycerine | Drug | |||
| noradrenaline | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Severity, decrease and duration of organ failure over the complete ICU stay | complete icu stay | |
| Duration of organ support | during ICU treatment | |
| ICU and hospital length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rutger v Raalte, MD | Contact | 0031205993007 | R.vanRaalte@olvg.nl | |
| Peter vd Voort, MD | Contact | 0031205993007 | P.H.J.vanderVoort@olvg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rutger v Raalte, MD | Onze Lieve Vrouwe Gasthuis, intensive care unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwe Gasthuis, intensive care | Recruiting | Amsterdam | 1090 HM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25032942 | Derived | van der Voort PH, van Zanten M, Bosman RJ, van Stijn I, Wester JP, van Raalte R, Oudemans-van Straaten HM, Zandstra DF. Testing a conceptual model on early opening of the microcirculation in severe sepsis and septic shock: a randomised controlled pilot study. Eur J Anaesthesiol. 2015 Mar;32(3):189-98. doi: 10.1097/EJA.0000000000000126. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004298 | Dopamine |
| D004280 | Dobutamine |
| D017335 | Enoximone |
| D005996 | Nitroglycerin |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| hospital stay |
| ICU and hospital mortality | hospital stay |
| Inflammatory response measured by IL-6/IL-10 | 72 hours |
| Plasma concentration of asymmetric dimethyl arginine (ADMA | 72 hours |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002395 |
| Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009574 | Nitro Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |