NCT00481442

Brief Summary

Clinical studies evaluating the clinical use of phenylephrine in septic shock are lacking. The present study was designed to compare the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

June 1, 2007

Status Verified

March 1, 2007

First QC Date

May 30, 2007

Last Update Submit

May 30, 2007

Conditions

Septic Shock

Keywords

Septic shockSepsisNorepinephrinePhenylephrine

Outcome Measures

Primary Outcomes (1)

  • Systemic and regional hemodynamics

    24 hours

Secondary Outcomes (1)

  • Organ functions, adverse effects

    24 hours

Interventions

PhenylephrineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clical diagnosis of Septic Shock
  • norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 12-18 mmHg and central venous pressure = 8-12 mmHg).

You may not qualify if:

  • Age \< 18 years
  • Pregnancy
  • Present or suspected acute coronary artery disease
  • Present or suspected acute mesenteric ischemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Andrea Morelli, MD

    Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

January 1, 2007

Study Completion

March 1, 2007

Last Updated

June 1, 2007

Record last verified: 2007-03

Locations

IT(1)