Phenylephrine in Septic Shock

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639015

Enrollment

Registered

2008-03-19

Start date

2007-11-30

Completion date

2008-06-30

Last updated

2017-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Keywords

Sepsis, Septic Shock, phenylephrine, norepinephrine, catecholamine

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.

Interventions

DRUGPhenylephrine

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

DRUGNorepinephrine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

* Pregnancy * Age \< 18 years * Present cardiac dysfunction * Present or suspected acute mesenteric ischemia

Design outcomes

Primary

Measure	Time frame
Systemic and regional hemodynamics	during the first 12 hours from the onset of septic shock

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026