Heart Rate Control With Esmolol in Septic Shock
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study|
- heart rate [ Time Frame: over a period of 96 hrs ] [ Designated as safety issue: No ]
- systemic hemodynamics [ Time Frame: over a period of 96 hours ] [ Designated as safety issue: No ]systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.
- ICU Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.
standard treatment without strict heart rate control
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231698
|Department of Anesthesiology and Intensive care of the University of Rome La Sapienza|
|Principal Investigator:||Andrea Morelli, MD||University of Roma La Sapienza|