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Esmolol Effects on Heart and Inflammation in Septic Shock (ESMOSEPSIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02068287
Recruitment Status : Unknown
Verified January 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : February 21, 2014
Last Update Posted : January 28, 2016
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Tracking Information
First Submitted Date  ICMJE January 29, 2014
First Posted Date  ICMJE February 21, 2014
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2) [ Time Frame: Before administration (H0) and each hour (H1-H2-H3-H4-H5-H6) during the whole administration period and one hour after Esmolol cessation (H7) ]
Compare, in septic shock patients, the mean cardiac index before and after administration of Esmolol.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • Effects on vasopressor requirement (amount of norepinephrine infused in microgram/kg) during Esmolol administration [ Time Frame: 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 [ Time Frame: Before (H0), 6 hours after Esmolol introduction (H6) and 1 hour after esmolol cessation (H7) ]
    NIRS (near-infrared spectroscopy) SDF (Sidestream Dark Field imaging) / Limon (non-invasive measurement of liver function and splanchnic perfusion monitoring) are used to asses microcirculatory and regional circulation effects
  • Changes in the Cytokine pattern(pro and anti inflammatory cytokines assay) induced by Esmolol administration in septic shock patients [ Time Frame: 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 [ Time Frame: Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation ]
    Use of Echocardiography to assess ventricular function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Esmolol Effects on Heart and Inflammation in Septic Shock
Official Title  ICMJE Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Septic Shock
Intervention  ICMJE 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.
Other Name: Brevibloc
Study Arms  ICMJE Experimental: ESMOLOL
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.
Intervention: Drug: Esmolol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 19, 2014)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Cardiogenic shock
  • Bradycardia
  • History of Severe Asthma
  • Indications against esmolol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02068287
Other Study ID Numbers  ICMJE 2012-004532-32
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Central Hospital, Nancy, France
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Central Hospital, Nancy, France
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Baxter Healthcare Corporation
Investigators  ICMJE
Principal Investigator: Bruno Levy, MD PhD CHU de Nancy
Principal Investigator: Antoine Kimmoun, MD CHU de Nancy
PRS Account Central Hospital, Nancy, France
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP