Septic Shock
Conditions
Keywords
Septic Shock, Hemodynamic, Inflammatory status, Beta adrenergic modulation, Esmolol
Brief summary
Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. Experimental works demonstrated that Esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono centric, double blind, randomized clinical work in septic shock patients has shown that Esmolol administration is safe and reduces effectively heart rate. However there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.
Interventions
DRUGEsmolol
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.
Sponsors
Baxter Healthcare Corporation
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* septic shock patients following the definition of the Surviving Sepsis Campaign * femoral and central venous catheters for thermodilution monitoring * fluid optimization * with a cardiac index \> 3 l/min/m2 * Heart Rate \>100 /min
Exclusion criteria
* Cardiogenic shock * Bradycardia * History of Severe Asthma * Indications against esmolol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects on vasopressor requirement (amount of norepinephrine infused in microgram/kg) during Esmolol administration | 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 | 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 | 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 | Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation | Use of Echocardiography to assess ventricular function |
Countries
France
Outcome results
None listed