DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Phenylephrine in Septic Shock

Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: Phenylephrine (Drug); Norepinephrine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Roma La Sapienza

Official(s) and/or principal investigator(s):
Andrea Morelli, M.D., Study Director, Affiliation: Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Systemic and regional hemodynamics

Secondary outcome: Organ functions,adverse effects

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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:

- Pregnancy

- Age < 18 years

- Present cardiac dysfunction

- Present or suspected acute mesenteric ischemia

Locations and Contacts

Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155, Rome 00161, Italy
Additional Information

Starting date: November 2007
Last updated: August 15, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017