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

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ClinicalTrials.gov Identifier: NCT02842983
Recruitment Status : Unknown
Verified July 2016 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Shock, Septic Drug: Esmolol Phase 2 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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 Name: beta blockers

No Intervention: Control
Patients received conventional management of septic shock



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Effects on vasopressor requirement [ Time Frame: over a period of 72 hrs ]
    Dosage of norepinephrine increased 100% compared with control group

  2. 90-day hospital mortality [ Time Frame: 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842983


Contacts
Contact: Yong-tai Liu, MD +861069155068 ataiever@163.com
Contact: Li Weng, MD +861069154035 wengli@pumch.cn

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yong-tai Liu, MD    +861069155068    ataiever@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Yong-tai Liu, MD Peking Union Medical College Hospital

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02842983     History of Changes
Other Study ID Numbers: esmolol sepsis
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to share individual participant data.

Keywords provided by Peking Union Medical College Hospital:
Esmolol
Hypotension
Shock, Septic
Sepsis
Systemic Inflammatory Response Syndrome
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs