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NCT00481442 Clinical Trial

Phenylephrine Versus Norepinephrine in Septic Shock

Septic Shock Clinical Trial

Official title:
Effects of Phenylephrine on Systemic and Regional Hemodynamics in Patients With Septic Shock: a Crossover Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00481442
Other study ID # 1125
Secondary ID
Status Completed
Phase Phase 2
First received May 30, 2007
Last updated May 30, 2007
Start date January 2007
Est. completion date March 2007

Study information
Verified date March 2007
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

Clinical studies evaluating the clinical use of phenylephrine in septic shock are lacking. The present study was designed to compare the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clical diagnosis of Septic Shock

- norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 12-18 mmHg and central venous pressure = 8-12 mmHg).

Exclusion Criteria:

- Age < 18 years

- Pregnancy

- Present or suspected acute coronary artery disease

- Present or suspected acute mesenteric ischemia.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Phenylephrine

Locations
Country Name City State
Italy Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza" 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 24 hours
Secondary Organ functions, adverse effects 24 hours
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