NCT01231698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 24, 2013

Status Verified

November 1, 2011

Enrollment Period

1.6 years

First QC Date

October 29, 2010

Last Update Submit

January 23, 2013

Conditions

Septic Shock

Keywords

septic shockesmololtachycardiabetablockers

Outcome Measures

Primary Outcomes (1)

  • heart rate

    over a period of 96 hrs

Secondary Outcomes (1)

  • systemic hemodynamics

    over a period of 96 hours

Other Outcomes (1)

  • ICU Mortality

    28 days

Study Arms (2)

esmolol

EXPERIMENTAL
Drug: esmolol

control

OTHER
Other: control

Interventions

esmololDRUG

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

esmolol
controlOTHER

standard treatment without strict heart rate control

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive care of the University of Rome La Sapienza

Rome, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24108526DERIVED

MeSH Terms

Conditions

Shock, SepticTachycardia

Interventions

esmolol

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System Disease

Study Officials

  • Andrea Morelli, MD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 1, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 24, 2013

Record last verified: 2011-11

Locations

IT(1)