Phenylephrine in Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639015
• Other study ID #: 1282
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2008
• Last updated: October 24, 2017
• Start date: November 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.
• Norepinephrine
Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.

Locations

Country	Name	City	State
Italy	Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic and regional hemodynamics		during the first 12 hours from the onset of septic shock
Secondary	Organ functions,adverse effects		during the first 12 hours from the onset of septic shock