We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phenylephrine Versus Norepinephrine in Septic Shock

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00481442
First Posted: June 1, 2007
Last Update Posted: June 1, 2007
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.
Information provided by:
University of Roma La Sapienza
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00481442     History of Changes
Other Study ID Numbers: 1125
First Submitted: May 30, 2007
First Posted: June 1, 2007
Last Update Posted: June 1, 2007
Last Verified: March 2007

Keywords provided by University of Roma La Sapienza:
Septic shock
Sepsis
Norepinephrine
Phenylephrine

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Phenylephrine
Oxymetazoline
Norepinephrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
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