Clinical trial NCT02068287: Esmolol Effects on Heart and Inflammation in Septic Shock
Official title: Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Septic Shock
Keywords: Septic Shock
Hemodynamic
Inflammatory status
Beta adrenergic modulation
Esmolol
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2)
timeFrame: Before administration (H0) and each hour (H1-H2-H3-H4-H5-H6) during the whole administration period and one hour after Esmolol cessation (H7)
Secondary outcomes:
measure: Effects on vasopressor requirement (amount of norepinephrine infused in microgram/kg) during Esmolol administration
timeFrame: 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)
measure: Microcirculatory and regional circulation effects of Esmolol in septic shock patient
timeFrame: Before (H0), 6 hours after Esmolol introduction (H6) and 1 hour after esmolol cessation (H7)
measure: Changes in the Cytokine pattern(pro and anti inflammatory cytokines assay) induced by Esmolol administration in septic shock patients
timeFrame: Before administration of Esmolol (H0) and 6 hours after introduction of Esmolol (H6)
measure: Description of the cardiac function during Esmolol Administration in septic shock patients
timeFrame: Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Bruno Levy, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Antoine Kimmoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy B, Fritz C, Piona C, Duarte K, Morelli A, Guerci P, Kimmoun A, Girerd N. Hemodynamic and anti-inflammatory effects of early esmolol use in hyperkinetic septic shock: a pilot study. Crit Care. 2021 Jan 7;25(1):21. doi: 10.1186/s13054-020-03445-w.