Phenylephrine in Septic Shock

University of Roma La Sapienza

Status and phase

Completed

Phase 2

Conditions

Septic Shock

Treatments

Drug: Phenylephrine

Drug: Norepinephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT00639015

1282

Details and patient eligibility

About

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

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of Septic shock
Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion criteria