Phenylephrine in Septic Shock

October 24, 2017 updated by: Andrea Morelli, University of Roma La Sapienza

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

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

  • Italy
      • Rome, Italy, 00161
        • Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155

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:

  • 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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Phenylephrine
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.
ACTIVE_COMPARATOR: 2
Norepinephrine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systemic and regional hemodynamics
Time Frame: during the first 12 hours from the onset of septic shock
during the first 12 hours from the onset of septic shock

Secondary Outcome Measures

Outcome Measure
Time Frame
Organ functions,adverse effects
Time Frame: during the first 12 hours from the onset of septic shock
during the first 12 hours from the onset of septic shock

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Study Director: Andrea Morelli, M.D., Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2007

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (ESTIMATE)

March 19, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1282

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.

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