Phenylephrine in Septic Shock
Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial
1 other identifier
interventional
32
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedOctober 26, 2017
October 1, 2017
7 months
March 12, 2008
October 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systemic and regional hemodynamics
during the first 12 hours from the onset of septic shock
Secondary Outcomes (1)
Organ functions,adverse effects
during the first 12 hours from the onset of septic shock
Study Arms (2)
1
EXPERIMENTALPhenylephrine
2
ACTIVE COMPARATORNorepinephrine
Interventions
Titrated phenylephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pregnancy
- Age \< 18 years
- Present cardiac dysfunction
- Present or suspected acute mesenteric ischemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155
Rome, 00161, Italy
Related Publications (1)
Morelli A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Laderchi A, Bachetoni A, D'Alessandro M, Van Aken H, Pietropaoli P, Westphal M. Phenylephrine versus norepinephrine for initial hemodynamic support of patients with septic shock: a randomized, controlled trial. Crit Care. 2008;12(6):R143. doi: 10.1186/cc7121. Epub 2008 Nov 18.
PMID: 19017409DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrea Morelli, M.D.
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 19, 2008
Study Start
November 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
October 26, 2017
Record last verified: 2017-10