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

Shock, Septic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02842983
• Other study ID #: esmolol sepsis
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 14, 2016
• Last updated: July 22, 2016
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Peking Union Medical College Hospital
• Contact: Yong-tai Liu, MD
• Phone: +861069155068
• Email: ataiever[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Intervention

Drug:
• Esmolol
conventional management plus esmolol infusion

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic assessment of heart function	peak systolic velocity measured at the mitral annulus decreased 30% compared with control group	over a period of 72 hrs	Yes
Secondary	Effects on vasopressor requirement	Dosage of norepinephrine increased 100% compared with control group	over a period of 72 hrs	No
Secondary	90-day hospital mortality		90 days	No