Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study
Overview
- Phase
- Phase 2
- Intervention
- Esmolol
- Conditions
- Septic Shock
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2)
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
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: Esmolol
Outcomes
Primary Outcomes
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 Outcomes
- 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))
- Microcirculatory and regional circulation effects of Esmolol in septic shock patient(Before (H0), 6 hours after Esmolol introduction (H6) and 1 hour after esmolol cessation (H7))
- 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))
- Description of the cardiac function during Esmolol Administration in septic shock patients(Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation)