A Phase 2 interventional study of esmolol and control in Septic Shock, sponsored by Andrea Morelli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by Andrea Morelli · Phase 2, Interventional, and Treatment
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.
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.
890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.
This study's enrollment of 154 is above the median of 78 across 547 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →This is the only study on the registry with Andrea Morelli as lead sponsor.
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Exclusion Criteria:
Drug: esmolol
Other: control
Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.
standard treatment without strict heart rate control
heart rate
Time frame: over a period of 96 hrs
systemic hemodynamics
systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.
Time frame: over a period of 96 hours
ICU Mortality
Time frame: 28 days
The record gives a start of Dec 2010, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esmolol