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Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

Primary Purpose

Shock, Septic

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Esmolol

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring Esmolol, Hypotension, Shock, Septic, Sepsis, Systemic Inflammatory Response Syndrome, Adrenergic beta-1 Receptor Antagonists, Adrenergic Antagonists, Pharmacologic Actions, Physiological Effects of Drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

septic shock
fluid optimization
with a cardiac index > 3 l/min/m2
Heart Rate >90 /min

Exclusion Criteria:

Cardiogenic shock
Bradycardia
History of Severe Asthma
Indications against Esmolol

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Esmolol

Control

Arm Description

After, at least six hours of hemodynamic optimization, patients with a hyperdynamic shock received a conventional management with a continuous infusion of Esmolol titrated to gain a 10% reduction in heart rate. This infusion is maintained for 72 hours.

Patients received conventional management of septic shock

Outcomes

Primary Outcome Measures

Echocardiographic assessment of heart function

peak systolic velocity measured at the mitral annulus decreased 30% compared with control group

Secondary Outcome Measures

Effects on vasopressor requirement

Dosage of norepinephrine increased 100% compared with control group

90-day hospital mortality

Full Information

NCT ID

NCT02842983

First Posted

July 14, 2016

Last Updated

July 22, 2016

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02842983

Brief Title

Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

Official Title

Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

After initial hemodynamic stabilization, 36 septic shock patients with heart rate > of 90 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will be randomised into two groups, esmolol group and control group. Patients allocated to esmolol group will receive a continuous esmolol infusion to maintain a lowering of heart rate of 10%. Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To investigate myocardial performance, the investigators will assess Tissue Doppler imaging by echocardiography and hemodynamic measures. Data will be obtained at baseline ,after esmolol infusion once achieved the predefined heart rate threshold and 72hours after esmolol infusion.

Detailed Description

primary outcome were determined according to our previous study of tissue doppler.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock, Septic

Keywords

Esmolol, Hypotension, Shock, Septic, Sepsis, Systemic Inflammatory Response Syndrome, Adrenergic beta-1 Receptor Antagonists, Adrenergic Antagonists, Pharmacologic Actions, Physiological Effects of Drugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Esmolol

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Patients received conventional management of septic shock

Intervention Type

Drug

Intervention Name(s)

Esmolol

Other Intervention Name(s)

beta blockers

Intervention Description

conventional management plus esmolol infusion

Primary Outcome Measure Information:

Title

Echocardiographic assessment of heart function

Description

peak systolic velocity measured at the mitral annulus decreased 30% compared with control group

Time Frame

over a period of 72 hrs

Secondary Outcome Measure Information:

Title

Effects on vasopressor requirement

Description

Dosage of norepinephrine increased 100% compared with control group

Time Frame

over a period of 72 hrs

Title

90-day hospital mortality

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: septic shock fluid optimization with a cardiac index > 3 l/min/m2 Heart Rate >90 /min Exclusion Criteria: Cardiogenic shock Bradycardia History of Severe Asthma Indications against Esmolol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yong-tai Liu, MD

Phone

+861069155068

ataiever@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li Weng, MD

Phone

+861069154035

wengli@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong-tai Liu, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yong-tai Liu, MD

Phone

+861069155068

ataiever@163.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is not a plan to share individual participant data.

Learn more about this trial

Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

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