Pilot Phase II Study: Hemodynamic Tolerance & Anti-inflammatory Effects of

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is : - to evaluate the hemodynamic tolerance of esmolol titrated to obtain a lowering of heart rate of 10% or 20%.

Clinical Trial Description

During septic shock, the consequences of treatment by a β1-blocker on inflammation and cardiovascular variability are unknown. The use of esmolol should have positive effects on inflammation and hemodynamic tolerance. These effects are probably dose-dependent. The study will enroll adult patients hospitalized in ICU, for severe septic shock requiring treatment by a vasopressor. A total of 45 patients will be included. Among these 45 patients, 15 patients will be randomized in the control group. 30 patients will be randomized to Esmolol with the objective to decrease heart rate by 10% (Group G10, n=15) or 20% (Group G20, n=15). Esmolol will be administered for 24 hours. This multicenter study will be performed in 3 investigation sites. The following parameters will be evaluated at different moments during the 28 days follow up of each patient, mainly: - Origin of sepsis, SOFA score. - Hemodynamic parameters will be continuously recorded for the 24 hours of experimental period. - Cardiovascular variability (arterial pressure and heart rate) will be recorded for 24 hours. - 3 echocardiograms at H0, H12 and H24 will be performed. - Biological parameters will be sampled at H0, H6, H12 and H24: They include standard biological parameters (Urea, Creatinin, Bilirubin,……) and specific parameters (catecholamines, vasopressin, insulin, cortisol, proinflammatory cytokines and anti-inflammatory cytokines. Dosages will be performed only at H0, H12 and H24 in order to study: - The expression of adrenergic receptors and their genetic polymorphisms on circulating immune cells. - The Th1/Th2 balance in immune cells. Each patient will be followed-up for 28 days. The variation of MAP and of cardiac output induced by esmolol should not exceed 15% of baseline values. If the variation is more important esmolol administration will be stopped and the hemodynamical tolerance will be defined as poor. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02120404
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	April 2015
Completion date	October 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pilot Phase II Study: Hemodynamic Tolerance and Anti-inflammatory Effects of Esmolol During the Treatment of Septic Shock — THANE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms