Esmolol Effects on Heart and Inflammation in Septic Shock (ESMOSEPSIS)
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|ClinicalTrials.gov Identifier: NCT02068287|
Recruitment Status : Unknown
Verified January 2016 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : February 21, 2014
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Drug: Esmolol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Resuscitated, hyperkinetic septic shock patients are treated with esmolol in order to reduce heart rate of 20% during 6 hours. During the intervention period, multimodal macro and micro hemodynamic data are recorded.
After, at least six hours of hemodynamic optimization, patients with an hyper dynamic shock received a conventional management with a continuous infusion of Esmolol titrated to gain a 20% reduction in heart rate. This infusion is maintained for six hours.
Other Name: Brevibloc
- Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2) [ Time Frame: Before administration (H0) and each hour (H1-H2-H3-H4-H5-H6) during the whole administration period and one hour after Esmolol cessation (H7) ]Compare, in septic shock patients, the mean cardiac index before and after administration of Esmolol.
- Effects on vasopressor requirement (amount of norepinephrine infused in microgram/kg) during Esmolol administration [ Time Frame: 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) ]
- Microcirculatory and regional circulation effects of Esmolol in septic shock patient [ Time Frame: Before (H0), 6 hours after Esmolol introduction (H6) and 1 hour after esmolol cessation (H7) ]NIRS (near-infrared spectroscopy) SDF (Sidestream Dark Field imaging) / Limon (non-invasive measurement of liver function and splanchnic perfusion monitoring) are used to asses microcirculatory and regional circulation effects
- Changes in the Cytokine pattern(pro and anti inflammatory cytokines assay) induced by Esmolol administration in septic shock patients [ Time Frame: Before administration of Esmolol (H0) and 6 hours after introduction of Esmolol (H6) ]
- Description of the cardiac function during Esmolol Administration in septic shock patients [ Time Frame: Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation ]Use of Echocardiography to assess ventricular function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068287
|CHU de Nancy||Recruiting|
|Nancy, France, 54511|
|Contact: Bruno Levy, MD PhD 0033383154469 firstname.lastname@example.org|
|Principal Investigator:||Bruno Levy, MD PhD||CHU de Nancy|
|Principal Investigator:||Antoine Kimmoun, MD||CHU de Nancy|