Esmolol Effects on Heart and Inflammation in Septic Shock

Septic Shock Clinical Trial

— ESMOSEPSIS  

Official title:

Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02068287
• Other study ID #: 2012-004532-32
• Status: Recruiting
• Phase: Phase 2
• First received: January 29, 2014
• Last updated: January 27, 2016
• Start date: December 2013
• Est. completion date: June 2017

Study information

• Verified date: January 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: ANSM:Agence Nationale de sécurité du Médicament
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

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.

Locations

Country	Name	City	State
France	CHU de Nancy	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Baxter Healthcare Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	Yes
Secondary	Microcirculatory and regional circulation effects of Esmolol in septic shock patient	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	Before (H0), 6 hours after Esmolol introduction (H6) and 1 hour after esmolol cessation (H7)	No
Secondary	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)	No
Secondary	Description of the cardiac function during Esmolol Administration in septic shock patients	Use of Echocardiography to assess ventricular function	Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation	Yes