Esmolol Effects on Heart and Inflammation in Septic Shock

Phase 2

• Conditions: Septic Shock
• Interventions: Drug: Esmolol

• Registration Number: NCT02068287
• Lead Sponsor: Central Hospital, Nancy, France

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 available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESMOLOL	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.

Primary Outcome Measures

Name	Time	Method
Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2)	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 Outcome Measures

Name	Time	Method
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)	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	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	Use of Echocardiography to assess ventricular function

Trial Locations

Locations (1)

CHU de Nancy; 🇫🇷 Nancy, France