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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

March 12, 2008
August 15, 2008
November 2007
June 2008   (final data collection date for primary outcome measure)
Systemic and regional hemodynamics [ Time Frame: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00639015 on ClinicalTrials.gov Archive Site
Organ functions,adverse effects [ Time Frame: during the first 12 hours from the onset of septic shock ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phenylephrine in Septic Shock
Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Septic Shock
  • 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.
  • 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.
  • Experimental: 1
    Phenylephrine
    Intervention: Drug: Phenylephrine
  • Active Comparator: 2
    Norepinephrine
    Intervention: Drug: Norepinephrine
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. Epub 2008 Nov 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00639015
1282
No
Andrea Morelli, University of Rome "La Sapienza"
University of Roma La Sapienza
Not Provided
Study Director: Andrea Morelli, M.D. Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
University of Roma La Sapienza
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP