Phenylephrine in Septic Shock

Phase 2

Completed

• Conditions: Septic Shock
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT00639015
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Phenylephrine	Phenylephrine
2	Norepinephrine	Norepinephrine

Primary Outcome Measures

Name	Time	Method
Systemic and regional hemodynamics	during the first 12 hours from the onset of septic shock

Secondary Outcome Measures

Name	Time	Method
Organ functions,adverse effects	during the first 12 hours from the onset of septic shock

Trial Locations

Locations (1)

Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155; 🇮🇹 Rome, Italy