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| Sponsored by: |
University of Roma La Sapienza |
|---|---|
| Information provided by: | University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT00639015 |
Purpose
The present study was conducted as a prospective, randomized, controlled study to compare:
| Condition | Intervention | Phase |
|---|---|---|
|
Septic Shock |
Drug: Phenylephrine Drug: Norepinephrine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial |
| Enrollment: | 32 |
| Study Start Date: | November 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Phenylephrine
|
Drug: Phenylephrine
Titrated phenylephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
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|
2: Active Comparator
Norepinephrine
|
Drug: Norepinephrine
Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
|
Thirty two septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. Patients will be randomly allocated to be treated with either a) titrated phenylephrine, b) titrated norepinephrine (control; each n = 16), to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, will be obtained at baseline and after 12 hours.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155 | |
| Rome, Italy, 00161 | |
| Study Director: | Andrea Morelli, M.D. | Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" |
More Information
| Responsible Party: | University of Rome "La Sapienza" ( Andrea Morelli ) |
| Study ID Numbers: | 1282 |
| Study First Received: | March 12, 2008 |
| Last Updated: | August 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00639015 History of Changes |
| Health Authority: | Italy: Ethics Committee |
|
Sepsis Septic Shock phenylephrine norepinephrine catecholamine |
|
Pseudoephedrine Systemic Inflammatory Response Syndrome Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Benzocaine Cardiovascular Agents Adrenergic Agonists Nasal Decongestants Inflammation |
Oxymetazoline Sepsis Mydriatics Shock Phenylephrine Shock, Septic Norepinephrine Vasoconstrictor Agents Ephedrine Peripheral Nervous System Agents |
|
Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Infection Adrenergic Agonists Nasal Decongestants Pathologic Processes Phenylephrine Therapeutic Uses Vasoconstrictor Agents Systemic Inflammatory Response Syndrome |
Adrenergic alpha-Agonists Sympathomimetics Cardiovascular Agents Protective Agents Pharmacologic Actions Inflammation Oxymetazoline Sepsis Mydriatics Shock Autonomic Agents Norepinephrine Shock, Septic Peripheral Nervous System Agents |
