Septic Shock
Conditions
Keywords
septic shock, esmolol, tachycardia, betablockers
Brief summary
The purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock.
Detailed description
154 septic shock patients with heart rate \> of 95 bpm and requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation, will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous esmolol infusion at any doses to maintain heart rate between 95 and 80 bpm b)to a standard treatment without heart rate control(control; each n = 77). In both groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization,data from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72, and 96 hours. The protocol will require that esmolol be infused continuously at any doses to maintain the predefined heart rate threshold until one the following events occur: the patient die, a serious adverse effect attributed to the study drug infusion, or the patient has been discharged from ICU.
Interventions
Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.
standard treatment without strict heart rate control
Sponsors
Study design
Eligibility
Inclusion criteria
* septic shock criteria * presence of heart rate \> 95 bpm.
Exclusion criteria
* Pregnancy * age \< 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| heart rate | over a period of 96 hrs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| systemic hemodynamics | over a period of 96 hours | systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects. |
Other
| Measure | Time frame |
|---|---|
| ICU Mortality | 28 days |
Countries
Italy