We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified January 2016 by Central Hospital, Nancy, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT02068287
First Posted: February 21, 2014
Last Update Posted: January 28, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Central Hospital, Nancy, France
  Purpose
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.

Condition Intervention Phase
Septic Shock Drug: Esmolol Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068287


Locations
France
CHU de Nancy Recruiting
Nancy, France, 54511
Contact: Bruno Levy, MD PhD    0033383154469    b.levy@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Baxter Healthcare Corporation
Investigators
Principal Investigator: Bruno Levy, MD PhD CHU de Nancy
Principal Investigator: Antoine Kimmoun, MD CHU de Nancy
  More Information

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02068287     History of Changes
Other Study ID Numbers: 2012-004532-32
First Submitted: January 29, 2014
First Posted: February 21, 2014
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Central Hospital, Nancy, France:
Septic Shock
Hemodynamic
Inflammatory status
Beta adrenergic modulation
Esmolol

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs