Heart Rate Control With Esmolol in Septic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Morelli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01231698
First received: October 29, 2010
Last updated: January 23, 2013
Last verified: November 2011
  Purpose

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 Intervention Phase
Septic Shock
Drug: esmolol
Other: control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • heart rate [ Time Frame: over a period of 96 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • systemic hemodynamics [ Time Frame: over a period of 96 hours ] [ Designated as safety issue: No ]
    systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.


Other Outcome Measures:
  • ICU Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: December 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • age < 18
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231698

Locations
Italy
Department of Anesthesiology and Intensive care of the University of Rome La Sapienza
Rome, Italy
Sponsors and Collaborators
Andrea Morelli
Investigators
Principal Investigator: Andrea Morelli, MD University of Roma La Sapienza
  More Information

No publications provided by University of Roma La Sapienza

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Morelli, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01231698     History of Changes
Other Study ID Numbers: 2048
Study First Received: October 29, 2010
Last Updated: January 23, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
septic shock
esmolol
tachycardia
betablockers

Additional relevant MeSH terms:
Shock
Shock, Septic
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014