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Esmolol Effects on Heart and Inflammation in Septic Shock

NCT02068287 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-01-28

No results posted yet for this study

Summary

Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. Experimental works demonstrated that Esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono centric, double blind, randomized clinical work in septic shock patients has shown that Esmolol administration is safe and reduces effectively heart rate. However there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.

Conditions

  • Septic Shock

Interventions

DRUG

Esmolol

After, at least six hours of hemodynamic optimization, patients with an hyper dynamic shock received a conventional management with a continuous infusion of Esmolol titrated to gain a 20% reduction in heart rate. This infusion is maintained for six hours.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Bruno Levy, MD PhD · Central Hospital, Nancy, France

  • Antoine Kimmoun, MD · Central Hospital, Nancy, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02068287 on ClinicalTrials.gov