- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00481442
Phenylephrine Versus Norepinephrine in Septic Shock
May 30, 2007 updated by: University of Roma La Sapienza
Effects of Phenylephrine on Systemic and Regional Hemodynamics in Patients With Septic Shock: a Crossover Pilot Study
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rome, Italy, 00161
- Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systemic and regional hemodynamics
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Organ functions, adverse effects
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrea Morelli, MD, Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
May 30, 2007
First Submitted That Met QC Criteria
May 30, 2007
First Posted (Estimate)
June 1, 2007
Study Record Updates
Last Update Posted (Estimate)
June 1, 2007
Last Update Submitted That Met QC Criteria
May 30, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Sepsis
- Shock, Septic
- Shock
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- 1125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Septic Shock
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German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnUnknownSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockGermany
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McMaster UniversityCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated...Recruiting
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Assistance Publique - Hôpitaux de ParisCompletedSeptic Shock HyperdynamicFrance
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University Medicine GreifswaldUnknownSepsis Septic ShockGermany
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Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
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University of ZurichCompletedPatients in Septic ShockSwitzerland
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National Taiwan University HospitalBaxter Healthcare CorporationRecruiting
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Charite University, Berlin, GermanyCompleted
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Centre Hospitalier Universitaire DijonCompleted
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Mansoura UniversityUnknown
Clinical Trials on Phenylephrine
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Cairo UniversityUnknownCesarean Section Complications | Spinal AnesthesiaEgypt
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Sun Yat-sen UniversityRecruitingPancreatic CancerChina
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The University of Texas at ArlingtonCompletedCardiovascular Diseases | Cardiovascular Risk Factor | VasoconstrictionUnited States
-
Montefiore Medical CenterCompletedCough Reflex SensitivityUnited States
-
Eyenovia Inc.Completed
-
Rabin Medical CenterCompletedInfection in Solid Organ Transplant RecipientsIsrael
-
Cairo UniversityCompletedCesarean Section Complications | Spinal AnesthesiaEgypt
-
IWK Health CentreDuke UniversityCompletedHypotensionUnited States, Canada
-
University of the PhilippinesCompleted
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BioLineRx, Ltd.Completed