Phenylephrine in Septic Shock

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00639015
First received: March 12, 2008
Last updated: August 15, 2008
Last verified: March 2008
  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 2

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:


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
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, see Learn About Clinical Studies.

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):
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
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Mydriatics
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014