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Sponsored by: |
Onze Lieve Vrouwe Gasthuis |
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Information provided by: | Onze Lieve Vrouwe Gasthuis |
ClinicalTrials.gov Identifier: | NCT00484133 |
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
Condition | Intervention | Phase |
---|---|---|
Severe Sepsis Microcirculation |
Drug: Dopamine Drug: dobutamine Drug: enoximone Drug: nitroglycerine Drug: noradrenaline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Estimated Enrollment: | 80 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rutger v Raalte, MD | 0031205993007 | R.vanRaalte@olvg.nl |
Contact: Peter vd Voort, MD | 0031205993007 | P.H.J.vanderVoort@olvg.nl |
Netherlands | |
Onze Lieve Vrouwe Gasthuis, intensive care | Recruiting |
Amsterdam, Netherlands, 1090 HM | |
Contact: Rutger v Raalte, MD 0031205993007 R.vanRaalte@olvg.nl | |
Principal Investigator: Rutger v Raalte, MD |
Principal Investigator: | Rutger v Raalte, MD | Onze Lieve Vrouwe Gasthuis, intensive care unit |
Responsible Party: | Onze Lieve Vrouwe gasthuis ( R. van Raalte ) |
Study ID Numbers: | WO-06.068 |
Study First Received: | June 6, 2007 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00484133 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
sepsis severe sepsis microcirculation Orthogonal polarisation spectral |
Nitroglycerin Systemic Inflammatory Response Syndrome Sepsis Dopamine |
Enoximone Norepinephrine Dobutamine Inflammation |
Vasodilator Agents Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents |
Infection Protective Agents Pharmacologic Actions Adrenergic Agonists Phosphodiesterase Inhibitors Pathologic Processes Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents |