Phenylephrine in Septic Shock
The present study was conducted as a prospective, randomized, controlled study to compare:
- the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock
- to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic perfusion versus phenylephrine in patients suffering from septic shock
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial|
- Systemic and regional hemodynamics [ Time Frame: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]
- Organ functions,adverse effects [ Time Frame: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Titrated phenylephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
Active Comparator: 2
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.
|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"|