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

• Status: Withdrawn
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Treatments: Esmolol

Criteria

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%