NCT02609152

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

Effect of a Continuous Infusion of Esmolol on Stroke Volume in Patients With Hyperdynamic Vasoplegic Septic Shock: a Multicentre, Randomized, Double-blind Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Shock, Septic

Interventions

Type	Name	Description
DRUG	Continuous perfusion of esmolol	In the experimental arm of the study, a continuous perfusion of esmolol will be performed. This infusion starts at 5 ml / h with an increase of 5 ml / hr every 10 minutes to obtain a 15% decrease in heart rate. The infusion will be reduced by 5 ml / h every 5 minutes if the cardiac rate is less than 90 beats per minute and stopped if it is less than 70 beats per minute. At H4, the doctor in charge is free to gradually continue or stop the infusion.
DRUG	Continuous perfusion of saline	In the control arm of the study, a continuous infusion of normal saline will be performed. This infusion starts at 5 ml / h with an increase of 5 ml / hr every 10 minutes to obtain a 15% decrease in heart rate. The infusion will be reduced by 5 ml / h every 5 minutes if the cardiac rate is less than 90 beats per minute and stopped if it is less than 70 beats per minute. A H4, the doctor in charge is free to gradually continue or stop the infusion.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2015-11-20
• Last updated: 2018-05-17

Locations

2 sites across 1 country: France