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

NCT02842983 | Unknown Phase 2

• 1 other identifier: esmolol sepsis
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Effects on vasopressor requirement

  over a period of 72 hrs

• 90-day hospital mortality

  90 days

Study Arms (2)

Esmolol

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients received conventional management of septic shock

Interventions

Esmolol DRUG

conventional management plus esmolol infusion

Also known as: beta blockers

Esmolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Hypotension; Sepsis; Systemic Inflammatory Response Syndrome

Interventions

esmolol; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Yong-tai Liu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-tai Liu, MD

CONTACT

+861069155068; ataiever@163.com

Li Weng, MD

CONTACT

+861069154035; wengli@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 25, 2016
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 25, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)