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

• ClinicalTrials.gov Identifier: NCT02068287
• Recruitment Status: Unknown
• First Posted: February 21, 2014
• Last Update Posted: January 28, 2016
• Sponsor: Central Hospital, Nancy, France
• Collaborator: Baxter Healthcare Corporation
• Information provided by (Responsible Party): Central Hospital, Nancy, France

Tracking Information

• First Submitted Date: January 29, 2014
• First Posted Date: February 21, 2014
• Last Update Posted Date: January 28, 2016
• Study Start Date: December 2013
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Esmolol Effects on Heart and Inflammation in Septic Shock
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Septic Shock

Intervention

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

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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 19, 2014): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2017
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02068287
• Other Study ID Numbers: 2012-004532-32
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Central Hospital, Nancy, France
• Original Responsible Party: Same as current
• Current Study Sponsor: Central Hospital, Nancy, France
• Original Study Sponsor: Same as current
• Collaborators: Baxter Healthcare Corporation

Investigators

• 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