Effect of a Continuous Infusion of Esmolol on Stroke Volume in Patients With Hyperdynamic Vasoplegic Septic Shock (BétaSep)

Centre Hospitalier Universitaire de Nīmes

Status and phase

Withdrawn

Phase 3

Conditions

Shock, Septic

Treatments

Drug: Continuous perfusion of saline

Drug: Continuous perfusion of esmolol

Study type

Interventional

Funder types

Other

Identifiers

NCT02609152

2015-000895-90 (EudraCT Number)

LOCAL/2014/ML-01

Details and patient eligibility

About

The main objective of this study is to evaluate the effectiveness of the administration of a short acting beta-blocker in terms of effective increase in stroke volume (at least 15%) after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile after 12-24 hours of care.

This research seeks to demonstrate that the proportion of patients with an increase in the systolic ejection superior or equal to 15% (relative to baseline) at four hours is different between the two arms of the study: (1) an experimental arm where patients receive an esmolol infusion according to a predetermined procedure and (2) a control arm where patients receive a saline infusion according to a predetermined procedure.

Full description

The secondary objectives are to compare the following items between the two arms of the study:

A. Central venous oxygen saturation at 4 hours (H4)

B. Changes in plasma concentration of lactates between H0 and H4

C. Changes in the tissue oxygen saturation between H0 and H4

D. Changes in echocardiographic parameters of systolic function of the left ventricle (LV) and right ventricle (RV), as well as diastolic LV function between H0 and H4

E. Vascular Filling volume during the study period

F. Kidney function: urine output and creatinine changes between H0 and H4

G. The required vasopressor time between H0 and H4

H. Use of positive inotropic agents

I. The inflammatory response via the analysis of HLA-DR between H0 and H4 and M1 / M2 responses at H4

J. The duration of ICU stay, mortality, morbidity in terms of organ failures

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient or his/her representative was informed about the implementation of the study, its objectives, constraints and patient rights or emergency consent
The patient or his/her representative must haven given free and informed consent and signed the consent or emergency consent
The patient must be affiliated with or the recipient of a health insurance plan
Septic shock criteria: shock for which the suspected or proven starting point is an infection requiring vasopressors after adequate fluid resuscitation that started within the past 24 to 72 hours
Precharge independence criteria obtained: i.e. pulsed pressure variation <13% or variation in ejection volume <10% or variation in the cardiac index after passive lift leg <10% or central venous pressure between 8 and 12 mmHg.
Antibiotic treatment in progress
Prescription ongoing vasopressor for 24 to 72 hours.
Sinus rhythm
Heart rate > 100 beats per minute
Cardiac Index measured by thermodilution greater than 4.0 l / min / m^2
Central venous oxygen saturation > 80% without positive inotropics such as dobutamine or isoproterenol (continuously taken or measured via central venous line in superior vena cava territory) on two successive samples in 12 hours
Monitoring of stroke volume (invasive, semi-invasive or ultrasound)

Exclusion criteria

The patient is participating in another study
The patient has participated in another study in the last 3 months
The patient is in an exclusion period determined by a previous study
The patient is under any kind of guardianship
The patient is under judicial protection
The patient or his/her representative refuses to sign the consent
It is impossible to correctly inform the patient
The patient is pregnant, parturient, or breastfeeding
The patient has a contraindication for a treatment used in this study
Cardiac index < 4.0 l / min / m^2
Need to introduce a positive inotropic agent (as determined by the physician in charge of the patient)
Contraindications to the use of esmolol: Severe sinus bradycardia (less than 50 beats per minute); Sinus pathologies, severe disorders of atrioventricular conduction (without pacemaker), atrioventricular blocks of second and third degree; Cardiogenic shock; Severe hypotension; Decompensated heart failure; Untreated pheochromocytoma; Pulmonary hypertension; Acute asthma attack; chronic obstructive pulmonary disease; peripheral arterial disease; Metabolic acidosis; Known hypersensitivity to esmolol.
Patient with kidney failure (RIFLE Stage L)
Chronic treatment with beta blocker
Patient with ultrasound assessment of left ventricular ejection fraction < 40%