Heart Rate Control With Esmolol in Septic Shock
Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock
Intervention: esmolol (Drug); control (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Andrea Morelli Official(s) and/or principal investigator(s): Andrea Morelli, MD, Principal Investigator, Affiliation: University of Roma La Sapienza
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.
Clinical Details
Official title: Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: heart rate
Secondary outcome: systemic hemodynamics
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- septic shock criteria
- presence of heart rate > 95 bpm.
Exclusion Criteria:
- Pregnancy
- age < 18
Locations and Contacts
Department of Anesthesiology and Intensive care of the University of Rome La Sapienza, Rome, Italy
Additional Information
Starting date: December 2010
Last updated: January 23, 2013
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