Heart Rate Control With Esmolol in Septic Shock

NCT ID: NCT01231698

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-07-31

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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

esmolol

Group Type: EXPERIMENTAL

esmolol

Intervention Type: DRUG

Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.

control

Group Type: OTHER

control

Intervention Type: OTHER

standard treatment without strict heart rate control

Interventions

esmolol

Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.

Intervention Type: DRUG

control

standard treatment without strict heart rate control

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• septic shock criteria
• presence of heart rate > 95 bpm.

Exclusion Criteria

• Pregnancy
• age < 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrea Morelli

OTHER

Sponsor Role: lead

Responsible Party

Andrea Morelli

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrea Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 24108526 (View on PubMed)

Other Identifiers

2048

Identifier Type: -

Identifier Source: org_study_id