Heart Rate Control With Esmolol in Septic Shock

Septic Shock Clinical Trial

Official title:

Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231698
• Other study ID #: 2048
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2010
• Last updated: January 23, 2013
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2011
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• septic shock criteria

• presence of heart rate > 95 bpm.

Exclusion Criteria:

• Pregnancy

• age < 18

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Other:
• control
standard treatment without strict heart rate control

Locations

Country	Name	City	State
Italy	Department of Anesthesiology and Intensive care of the University of Rome La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Andrea Morelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU Mortality		28 days	No
Primary	heart rate		over a period of 96 hrs	No
Secondary	systemic hemodynamics	systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.	over a period of 96 hours	No