Phenylephrine Versus Norepinephrine in Septic Shock

This study has been completed.

Sponsor:

Information provided by:

University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT00481442

First received: May 30, 2007

Last updated: NA

Last verified: March 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

May 30, 2007

Start Date ^ICMJE

January 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Systemic and regional hemodynamics [ Time Frame: 24 hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Organ functions, adverse effects [ Time Frame: 24 hours ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phenylephrine Versus Norepinephrine in Septic Shock

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Septic Shock

Intervention ^ICMJE

Drug: Phenylephrine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00481442

Other Study ID Numbers ^ICMJE

1125

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Roma La Sapienza

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Andrea Morelli, MD

Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"

Information Provided By

University of Roma La Sapienza

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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