Back to resultsPhenylephrine Versus Norepinephrine in Septic Shock
Primary Purpose
Septic Shock
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring Septic shock, Sepsis, Norepinephrine, Phenylephrine
Eligibility 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.
Sites / Locations
- Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
Outcomes
Primary Outcome Measures
Systemic and regional hemodynamics
Secondary Outcome Measures
Organ functions, adverse effects
Full Information
NCT ID
NCT00481442
First Posted
May 30, 2007
Last Updated
May 30, 2007
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT00481442
Brief Title
Phenylephrine Versus Norepinephrine in Septic Shock
Official Title
Effects of Phenylephrine on Systemic and Regional Hemodynamics in Patients With Septic Shock: a Crossover Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Septic shock, Sepsis, Norepinephrine, Phenylephrine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Primary Outcome Measure Information:
Title
Systemic and regional hemodynamics
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Organ functions, adverse effects
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Morelli, MD
Organizational Affiliation
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
City
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
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Phenylephrine Versus Norepinephrine in Septic Shock
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