Esmolol Effects on Heart and Inflammation in Septic Shock

Condition(s) targeted: Septic Shock

Intervention: Esmolol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Central Hospital, Nancy, France

Official(s) and/or principal investigator(s):
Bruno Levy, MD PhD, Principal Investigator, Affiliation: CHU de Nancy
Antoine Kimmoun, MD, Principal Investigator, Affiliation: CHU de Nancy

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.

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

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

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

Secondary outcome:

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

Microcirculatory and regional circulation effects of Esmolol in septic shock patient

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

CHU de Nancy, Nancy 54511, France; Recruiting
Bruno Levy, MD PhD, Phone: 0033383154469, Email: b.levy@chu-nancy.fr

Starting date: December 2013
Last updated: February 19, 2014