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

October 29, 2010
January 23, 2013
December 2010
July 2012   (final data collection date for primary outcome measure)
heart rate [ Time Frame: over a period of 96 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01231698 on ClinicalTrials.gov Archive Site
systemic hemodynamics [ Time Frame: over a period of 96 hours ] [ Designated as safety issue: No ]
systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.
Same as current
ICU Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
 
Heart Rate Control With Esmolol in Septic Shock
Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Septic Shock
  • 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
  • Experimental: esmolol
    Intervention: Drug: esmolol
  • control
    Intervention: Other: control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • age < 18
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01231698
2048
No
Andrea Morelli, University of Roma La Sapienza
Andrea Morelli
Not Provided
Principal Investigator: Andrea Morelli, MD University of Roma La Sapienza
University of Roma La Sapienza
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP