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Heart Rate Control With Esmolol in Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01231698
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Andrea Morelli, University of Roma La Sapienza

Tracking Information
First Submitted Date  ICMJE October 29, 2010
First Posted Date  ICMJE November 1, 2010
Last Update Posted Date January 24, 2013
Study Start Date  ICMJE December 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
heart rate [ Time Frame: over a period of 96 hrs ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01231698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2010)
systemic hemodynamics [ Time Frame: over a period of 96 hours ]
systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2013)
ICU Mortality [ Time Frame: 28 days ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Rate Control With Esmolol in Septic Shock
Official Title  ICMJE Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Septic Shock
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: esmolol
    Intervention: Drug: esmolol
  • control
    Intervention: Other: control
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)
154
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2010)
40
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • age < 18
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01231698
Other Study ID Numbers  ICMJE 2048
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Morelli, University of Roma La Sapienza
Study Sponsor  ICMJE Andrea Morelli
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Morelli, MD University of Roma La Sapienza
PRS Account University of Roma La Sapienza
Verification Date November 2011

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