Phenylephrine Versus Norepinephrine in Septic Shock

This study has been completed.

First Received: May 30, 2007 No Changes Posted

Sponsored by:	University of Roma La Sapienza
Information provided by:	University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT00481442

Purpose

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.

Condition	Intervention	Phase
Septic Shock	Drug: Phenylephrine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of Phenylephrine on Systemic and Regional Hemodynamics in Patients With Septic Shock: a Crossover Pilot Study

Resource links provided by NLM:

Drug Information available for: Norepinephrine Phenylephrine Phenylephrine hydrochloride Norepinephrine bitartrate Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:

Systemic and regional hemodynamics [ Time Frame: 24 hours ]

Secondary Outcome Measures:

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

Enrollment:	15
Study Start Date:	January 2007
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481442

Locations

Italy
Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
Rome, Italy, 00161

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Principal Investigator:

Andrea Morelli, MD

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

More Information

No publications provided

Study ID Numbers:	1125
Study First Received:	May 30, 2007
Last Updated:	May 30, 2007
ClinicalTrials.gov Identifier:	NCT00481442 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:

Septic shock
Sepsis
Norepinephrine
Phenylephrine

Study placed in the following topic categories:

Pseudoephedrine
Systemic Inflammatory Response Syndrome
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Cardiovascular Agents
Adrenergic Agonists
Nasal Decongestants
Inflammation
Oxymetazoline

Sepsis
Mydriatics
Shock
Phenylephrine
Shock, Septic
Norepinephrine
Vasoconstrictor Agents
Ephedrine
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Infection
Adrenergic Agonists
Nasal Decongestants
Pathologic Processes
Phenylephrine
Therapeutic Uses
Vasoconstrictor Agents
Systemic Inflammatory Response Syndrome

Adrenergic alpha-Agonists
Sympathomimetics
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Inflammation
Oxymetazoline
Sepsis
Mydriatics
Shock
Autonomic Agents
Norepinephrine
Shock, Septic
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009