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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Sepsis Shock
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

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

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
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 June 17, 2013