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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02842983
Enrollment
36
Registered
2016-07-25
Start date
2014-12-31
Completion date
2016-12-31
Last updated
2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGEsmolol

conventional management plus esmolol infusion

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Echocardiographic assessment of heart functionover a period of 72 hrspeak systolic velocity measured at the mitral annulus decreased 30% compared with control group

Secondary

MeasureTime frameDescription
Effects on vasopressor requirementover a period of 72 hrsDosage of norepinephrine increased 100% compared with control group
90-day hospital mortality90 days

Countries

China

Contacts

Primary ContactYong-tai Liu, MD
ataiever@163.com+861069155068
Backup ContactLi Weng, MD
wengli@pumch.cn+861069154035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026