Heart Rate Control With Esmolol in Septic Shock | NCT01231698

Studies
Heart Rate Control With Esmolol in Septic Shock

NCT01231698

Sponsor

Andrea Morelli

Status

Completed

Last Update Posted

Jan 24, 2013Estimated

Enrollment

154Actual

Phase

Phase 2

Conditions

Septic Shock

Interventions

esmolol
control

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Oct 29, 2010

First Submission Date that Met QC Criteria

Oct 29, 2010

First Posted Date

Nov 1, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2013

Last Update Posted Date

Jan 24, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

154Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
esmolol	Experimental		Drug: esmolol
control	Other		Other: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
esmolol	Drug	Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.	esmolol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
heart rate		over a period of 96 hrs

Secondary Outcomes

Measure	Description	Time Frame
systemic hemodynamics	systemic hemodynamics,norepinephrine requirements,organ functions,adverse effects.	over a period of 96 hours

Other Outcomes

Measure	Description	Time Frame
ICU Mortality		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

septic shock criteria
presence of heart rate > 95 bpm.

Exclusion Criteria:

Pregnancy
age < 18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Morelli, MD	University of Roma La Sapienza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Intensive care of the University of Rome La Sapienza		Rome			Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42402640	Derived	Huang X, Zheng M, Zhu Z, Zhang Y, Chen KY. Association of anti-catecholaminergic antiarrhythmic drugs with survival in sepsis-associated new-onset atrial fibrillation. Sci Rep. 2026 Jul 6;16(1):20588. doi: 10.1038/s41598-026-51249-9.
24108526	Derived	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.

ID	Term
D012772	Shock, Septic
D013610	Tachycardia

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation