CClinicalTrials.gg
Status unknownNCT02842983Updated Jul 25, 2016

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

A Phase 2/3 interventional study of Esmolol in Shock, Septic, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-25.

Sponsored by Peking Union Medical College Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • 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
03

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's planned enrollment of 36 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Cardiogenic shock
  • Bradycardia
  • History of Severe Asthma
  • Indications against Esmolol
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • 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

  • No intervention
    Control

    Patients received conventional management of septic shock

Interventions

  • DrugEsmolol

    conventional management plus esmolol infusion

    Also known as: beta blockers

06

What researchers measure

Primary outcomes

  1. Echocardiographic assessment of heart function

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

    Time frame: over a period of 72 hrs

Secondary outcomes

  1. Effects on vasopressor requirement

    Dosage of norepinephrine increased 100% compared with control group

    Time frame: over a period of 72 hrs

  2. 90-day hospital mortality

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — There is not a plan to share individual participant data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02842983
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Jul 25, 2016
Start date
Dec 2014
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 25, 2016

Study contacts

Yong-tai Liu, MD
Contact
ataiever@163.com
+861069155068
Li Weng, MD
Contact
wengli@pumch.cn
+861069154035
Yong-tai Liu, MD
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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