NCT00639015

Phenylephrine in Septic Shock

Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-03-19
• Last updated: 2017-10-26

Locations

1 site across 1 country: Italy