Phenylephrine in Septic Shock - Full Text View

Sponsor:	University of Roma La Sapienza
Information provided by:	University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT00639015

Purpose

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

Condition	Intervention	Phase
Septic Shock	Drug: Phenylephrine Drug: Norepinephrine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock

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: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Organ functions,adverse effects [ Time Frame: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]

Enrollment:	32
Study Start Date:	November 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Phenylephrine	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.
Active Comparator: 2 Norepinephrine	Drug: Norepinephrine Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of 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.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639015

Locations

Italy
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155
Rome, Italy, 00161

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Study Director:

Andrea Morelli, M.D.

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

More Information

No publications provided by University of Roma La Sapienza

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Morelli A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Laderchi A, Bachetoni A, D'Alessandro M, Van Aken H, Pietropaoli P, Westphal M. Phenylephrine versus norepinephrine for initial hemodynamic support of patients with septic shock: a randomized, controlled trial. Crit Care. 2008;12(6):R143. Epub 2008 Nov 18.

Responsible Party:	Andrea Morelli, University of Rome "La Sapienza"
ClinicalTrials.gov Identifier:	NCT00639015 History of Changes
Other Study ID Numbers:	1282
Study First Received:	March 12, 2008
Last Updated:	August 15, 2008
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:

Sepsis
Septic Shock
phenylephrine
norepinephrine
catecholamine

Additional relevant MeSH terms:

Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Phenylephrine
Oxymetazoline
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012