Phenylephrine Versus Norepinephrine in Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481442
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : June 1, 2007
Information provided by:
University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Phenylephrine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Phenylephrine on Systemic and Regional Hemodynamics in Patients With Septic Shock: a Crossover Pilot Study
Study Start Date : January 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Primary Outcome Measures :
  1. Systemic and regional hemodynamics [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Organ functions, adverse effects [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00481442

Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Principal Investigator: Andrea Morelli, MD Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Identifier: NCT00481442     History of Changes
Other Study ID Numbers: 1125
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: June 1, 2007
Last Verified: March 2007

Keywords provided by University of Roma La Sapienza:
Septic shock

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents