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Phenylephrine in Septic Shock

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Phenylephrine
Norepinephrine
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Sepsis, Septic Shock, phenylephrine, norepinephrine, catecholamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Phenylephrine

Norepinephrine

Outcomes

Primary Outcome Measures

Systemic and regional hemodynamics

Secondary Outcome Measures

Organ functions,adverse effects

Full Information

First Posted
March 12, 2008
Last Updated
October 24, 2017
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT00639015
Brief Title
Phenylephrine in Septic Shock
Official Title
Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Sepsis, Septic Shock, phenylephrine, norepinephrine, catecholamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Phenylephrine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Norepinephrine
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
Titrated phenylephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Titrated norepinephrine to maintain mean arterial pressure between 65-75 mmHg over a period of 12 hours from the onset of septic shock.
Primary Outcome Measure Information:
Title
Systemic and regional hemodynamics
Time Frame
during the first 12 hours from the onset of septic shock
Secondary Outcome Measure Information:
Title
Organ functions,adverse effects
Time Frame
during the first 12 hours from the onset of septic shock

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Morelli, M.D.
Organizational Affiliation
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
Official's Role
Study Director
Facility Information:
Facility Name
Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155
City
Rome
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19017409
Citation
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.
Results Reference
derived

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Phenylephrine in Septic Shock

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