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Tracking Information | |||||
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First Received Date † | December 22, 2005 | ||||
Last Updated Date | May 26, 2006 | ||||
Start Date † | July 2000 | ||||
Current Primary Outcome Measures † |
To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00269685 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Comparison of Vasopressin and Other Pressors in Septic Shock | ||||
Official Title † | Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock | ||||
Brief Summary | The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor. Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect. |
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Detailed Description | |||||
Study Phase | Phase II, Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||
Condition † | Shock, Septic | ||||
Intervention † | Drug: vasopressin | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 20 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
The time window between beginning of symptoms and onset of treatment is established at 12 hours. The patient must be intubated and mechanically ventilated. Patient presenting a mean arterial blood pressure of less than 60 mm Hg after adequate fluid resuscitation (at least 1 L of colloid or crystalloid) and 10 ug/Kg/min of dopamine. Patient presenting a cardiac index of at least 3 L/min/m2 Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00269685 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Universitaire de Sherbrooke | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Universitaire de Sherbrooke | ||||
Verification Date | August 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |