Heart Rate Control With Esmolol in Septic Shock

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ClinicalTrials.gov Identifier: NCT01231698

Recruitment Status : Completed

First Posted : November 1, 2010

Last Update Posted : January 24, 2013

Sponsor:

Information provided by (Responsible Party):

Andrea Morelli, University of Roma La Sapienza

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.

Condition or disease	Intervention/treatment	Phase
Septic Shock	Drug: esmolol Other: control	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	154 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study
Study Start Date :	December 2010
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Drug Information available for: Esmolol Esmolol hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: esmolol	Drug: esmolol Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.
control	Other: control standard treatment without strict heart rate control

Outcome Measures

Primary Outcome Measures :

heart rate [ Time Frame: over a period of 96 hrs ]

Secondary Outcome Measures :

systemic hemodynamics [ Time Frame: over a period of 96 hours ]
systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.

Other Outcome Measures:

ICU Mortality [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

septic shock criteria
presence of heart rate > 95 bpm.

Exclusion Criteria:

Pregnancy
age < 18

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231698

Locations

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Italy
Department of Anesthesiology and Intensive care of the University of Rome La Sapienza
Rome, Italy

Sponsors and Collaborators

Andrea Morelli

Investigators

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Principal Investigator:	Andrea Morelli, MD	University of Roma La Sapienza

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Andrea Morelli, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT01231698
Other Study ID Numbers:	2048
First Posted:	November 1, 2010 Key Record Dates
Last Update Posted:	January 24, 2013
Last Verified:	November 2011

Keywords provided by Andrea Morelli, University of Roma La Sapienza:


septic shock esmolol tachycardia betablockers

Additional relevant MeSH terms:

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Shock, Septic Shock Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Esmolol	Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

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