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

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 2

Conditions: Septic Shock

Treatments: Drug: Esmolol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02068287

2012-004532-32

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

ESMOLOL

Experimental group

Description:

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.

Treatment:

Drug: Esmolol