Phenylephrine in Septic Shock
Information source: University of Roma La Sapienza
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock
Intervention: Phenylephrine (Drug); Norepinephrine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Roma La Sapienza Official(s) and/or principal investigator(s):
Andrea Morelli, M.D., Study Director, Affiliation: Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
Overall contact:
Andrea Morelli, M.D., Phone: +390649978024, Email: andrea.morelli@uniroma1.it
Summary
The present study was conducted as a prospective, randomized, controlled study to compare: A)
the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in
patients with catecholamine-dependent septic shock. B)to test the hypothesis that
norepinephrine may likewise better preserve hepatosplanchnic perfusion versus phenylephrine
in patients suffering from septic shock.
Clinical Details
Official title: Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Systemic and regional hemodynamics
Secondary outcome: Organ functions,adverse effects
Detailed description:
Thirty 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 = 15), 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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Andrea Morelli, M.D., Phone: +390649978024, Email: andrea.morelli@uniroma1.it
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155, Rome 00161, Italy; Recruiting
Additional Information
Starting date: November 2007
Ending date: May 2008
Last updated: March 12, 2008
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