NCT02750683

Brief Summary

Norepinephrine (NE) is a potent vasopressor used in septic shock to reverse hypotension. Early infusion of NE was associated with a favorable clinical outcome in a large cohort of patients . When administered early, NE increases cardiac output (CO) in patients with septic shock . This effect was suggested to be mainly related to an increased cardiac preload via the α-adrenergic-mediated decrease in systemic venous capacitance . Whether NE exerts a positive effect on cardiac contractility through β1-adrenergic stimulation is unclear. On the one hand, the sensitivity of β1-adrenergic receptors can be abnormally reduced in septic conditions. On the other hand, such a sepsis-induced down-regulation of β1-adrenergic receptors may occur relatively late and thus, might not be observed when NE is administered early. Our study was designed to examine the inotropic effects of NE when administered in the early phase of human septic shock

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

April 21, 2016

Last Update Submit

April 25, 2016

Conditions

Septic Shock

Keywords

inotropic effect, norepinephrine, septic shock,

Outcome Measures

Primary Outcomes (1)

  • The changes in left ventricular ejection fraction

    2 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an age of more than 18 years old, admitted to intensive care unit with septic shock and a mean arterial pressure of less than 65mmHg.

You may qualify if:

  • Age more than 18 years old
  • Septic shock
  • Mean arterial pressure\<65mmHg

You may not qualify if:

  • Age less than 18 yeras old
  • Pregnancy
  • moribond patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hamzaoui O, Jozwiak M, Geffriaud T, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Richard C, Teboul JL. Norepinephrine exerts an inotropic effect during the early phase of human septic shock. Br J Anaesth. 2018 Mar;120(3):517-524. doi: 10.1016/j.bja.2017.11.065. Epub 2017 Nov 21.

    PMID: 29452808DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Olfa Hamzaoui, MD

    Hopital Antoine Beclere

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 25, 2016

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share