Heart Rate Control With Esmolol in Septic Shock

Phase 2

Completed

• Conditions: Septic Shock
• Interventions: Other: control; Drug: esmolol

• Registration Number: NCT01231698
• Lead Sponsor: Andrea Morelli

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.

Study Timeline

• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-10-29
• Study First Posted: 2010-11-01
• Study Start: 2010-12
• Status Verified: 2011-11
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• age < 18

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	-
esmolol	esmolol	-

Primary Outcome Measures

Name	Time	Method
heart rate	over a period of 96 hrs

Secondary Outcome Measures

Name	Time	Method
systemic hemodynamics	over a period of 96 hours	systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.

Trial Locations

Locations (1)

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