NCT02068287

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

3 years

First QC Date

January 29, 2014

Last Update Submit

January 27, 2016

Conditions

Septic Shock

Keywords

Septic ShockHemodynamicInflammatory statusBeta adrenergic modulationEsmolol

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2)

    Compare, in septic shock patients, the mean cardiac index before and after administration of Esmolol.

    Before administration (H0) and each hour (H1-H2-H3-H4-H5-H6) during the whole administration period and one hour after Esmolol cessation (H7)

Secondary Outcomes (4)

  • Effects on vasopressor requirement (amount of norepinephrine infused in microgram/kg) during Esmolol administration

    Record of each change in vasopressor dosage to maintain a mean arterial pressure at 70 mmHg during the whole Esmolol administration period (H0 to H6) and one hour after esmolol cessation (H7)

  • Microcirculatory and regional circulation effects of Esmolol in septic shock patient

    Before (H0), 6 hours after Esmolol introduction (H6) and 1 hour after esmolol cessation (H7)

  • Changes in the Cytokine pattern(pro and anti inflammatory cytokines assay) induced by Esmolol administration in septic shock patients

    Before administration of Esmolol (H0) and 6 hours after introduction of Esmolol (H6)

  • Description of the cardiac function during Esmolol Administration in septic shock patients

    Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation

Study Arms (1)

ESMOLOL

EXPERIMENTAL

Resuscitated, hyperkinetic septic shock patients are treated with esmolol in order to reduce heart rate of 20% during 6 hours. During the intervention period, multimodal macro and micro hemodynamic data are recorded.

Drug: Esmolol

Interventions

EsmololDRUG

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.

Also known as: Brevibloc
ESMOLOL

Eligibility Criteria

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

You may qualify if:

  • septic shock patients following the definition of the Surviving Sepsis Campaign
  • femoral and central venous catheters for thermodilution monitoring
  • fluid optimization
  • with a cardiac index \> 3 l/min/m2
  • Heart Rate \>100 /min

You may not qualify if:

  • Cardiogenic shock
  • Bradycardia
  • History of Severe Asthma
  • Indications against esmolol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nancy

Nancy, 54511, France

RECRUITING

Related Publications (1)

  • Levy B, Fritz C, Piona C, Duarte K, Morelli A, Guerci P, Kimmoun A, Girerd N. Hemodynamic and anti-inflammatory effects of early esmolol use in hyperkinetic septic shock: a pilot study. Crit Care. 2021 Jan 7;25(1):21. doi: 10.1186/s13054-020-03445-w.

    PMID: 33413583DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

esmolol

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Bruno Levy, MD PhD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

  • Antoine Kimmoun, MD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 21, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

FR(1)