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Heart Rate Control With Esmolol in Septic Shock

Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Septic Shock

Intervention: esmolol (Drug); control (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Andrea Morelli

Official(s) and/or principal investigator(s):
Andrea Morelli, MD, Principal Investigator, Affiliation: University of Roma La Sapienza

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.

Clinical Details

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

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

Primary outcome: heart rate

Secondary outcome: systemic hemodynamics

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- septic shock criteria

- presence of heart rate > 95 bpm.

Exclusion Criteria:

- Pregnancy

- age < 18

Locations and Contacts

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

Starting date: December 2010
Last updated: January 23, 2013

Page last updated: August 20, 2015

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