Back to resultsHeart Rate Control With Esmolol in Septic Shock
Primary Purpose
Septic Shock
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
esmolol
control
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring septic shock, esmolol, tachycardia, betablockers
Eligibility Criteria
Inclusion Criteria:
- septic shock criteria
- presence of heart rate > 95 bpm.
Exclusion Criteria:
- Pregnancy
- age < 18
Sites / Locations
- Department of Anesthesiology and Intensive care of the University of Rome La Sapienza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
esmolol
control
Arm Description
Outcomes
Primary Outcome Measures
heart rate
Secondary Outcome Measures
systemic hemodynamics
systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01231698
Brief Title
Heart Rate Control With Esmolol in Septic Shock
Official Title
Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrea Morelli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, esmolol, tachycardia, betablockers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
esmolol
Arm Type
Experimental
Arm Title
control
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
esmolol
Intervention Description
Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
standard treatment without strict heart rate control
Primary Outcome Measure Information:
Title
heart rate
Time Frame
over a period of 96 hrs
Secondary Outcome Measure Information:
Title
systemic hemodynamics
Description
systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.
Time Frame
over a period of 96 hours
Other Pre-specified Outcome Measures:
Title
ICU Mortality
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
septic shock criteria
presence of heart rate > 95 bpm.
Exclusion Criteria:
Pregnancy
age < 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Morelli, MD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive care of the University of Rome La Sapienza
City
Rome
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24108526
Citation
Morelli A, Ertmer C, Westphal M, Rehberg S, Kampmeier T, Ligges S, Orecchioni A, D'Egidio A, D'Ippoliti F, Raffone C, Venditti M, Guarracino F, Girardis M, Tritapepe L, Pietropaoli P, Mebazaa A, Singer M. Effect of heart rate control with esmolol on hemodynamic and clinical outcomes in patients with septic shock: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1683-91. doi: 10.1001/jama.2013.278477.
Results Reference
derived
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Heart Rate Control With Esmolol in Septic Shock
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