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

July 22, 2016 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esmolol
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.
Drug: Esmolol
conventional management plus esmolol infusion
Other Names:
  • beta blockers
No Intervention: Control
Patients received conventional management of septic shock

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiographic assessment of heart function
Time Frame: over a period of 72 hrs
peak systolic velocity measured at the mitral annulus decreased 30% compared with control group
over a period of 72 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on vasopressor requirement
Time Frame: over a period of 72 hrs
Dosage of norepinephrine increased 100% compared with control group
over a period of 72 hrs
90-day hospital mortality
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Yong-tai Liu, MD, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • esmolol sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to share individual participant data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Shock, Septic

Clinical Trials on Esmolol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe