Effects of Heart Control at Different Stages in Patients of Septic Shock With Tachycardia

NCT05389176 | Unknown

• 1 other identifier: 2022-038-02
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

A sigle-center, randomized controlled trial will be do to investigate the effects of esomol on heart rate, clinical parameters, mortality, and safety in septic shock patients with tachycardia at different stages, compared with patients who received conventional therapy.

Conditions

Septic Shock; Tachycardia

Keywords

Septic Shock; Tachycardia; β receptor blockers

Outcome Measures

Primary Outcomes (4)

• the proportion of patients with heart rate of 70-100 bpm

  the proportion of patients with heart rate of 70-100 bpm

  at 24-hour after randomization

• the proportion of patients with heart rate of 70-100 bpm

  the proportion of patients with heart rate of 70-100 bpm

  at 48-hour after randomization

• the proportion of patients with heart rate of 70-100 bpm

  the proportion of patients with heart rate of 70-100 bpm

  at 72-hour after randomization

• the proportion of patients with heart rate of 70-100 bpm

  the proportion of patients with heart rate of 70-100 bpm

  at 96-hour after randomization

Secondary Outcomes (33)

• cardiac index

  at 24-hour after randomization

• cardiac index

  at 48-hour after randomization

• cardiac index

  at 72-hour after randomization

• cardiac index

  at 96-hour after randomization

• ejection fraction

  at 24-hour after randomization

Study Arms (3)

Group A

EXPERIMENTAL

Esmolol is used 6 to 24 hours after onset of septic shock in patients with fluid optimization to control heart beats between 70-100bpm.

Drug: Esmolol

Group B

EXPERIMENTAL

Esmolol is used 24 hours after onset of septic shock in patients to control heart beats between 70-100bpm.

Drug: Esmolol

Group C

NO INTERVENTION

patients received conventional therapy in accordance with septic shock guidelines 2021

Interventions

Esmolol DRUG

a continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min

Also known as: β-receptor blockers

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• " ≥ 18 years old; " New septic shock within 24 hours, meeting the diagnostic criteria in 2012; " Septic shock lasts for more than 6 hours, and after fluid optimization using dynamic parameters, vasoactive drugs are still needed to maintain blood pressure; " the heart rate is greater than 100 beats / min for ≥ 1 hour，not caused by agitation, fever, and other factors; " informed consents are signed.

You may not qualify if:

• " Shock caused by sepsis; " Septic cardiomyopathy or decreased myocardial contractility, requiring the use of positive inotropic drugs or significant cardiac insufficiency, such as CI ≤ 2.2l/min m2, PAWP\>18mmHg, EF\<40%; " Severe bronchial asthma or COPD; " Pregnant or lactating women; " Sinus bradycardia, degree II and degree III heart block; " β-receptor blockers were used before enrollment or have the history of sinus tachycardia; " Severe valvular heart disease; " Allergic to esmolol; " Tachycardia due to elevated body temperature, agitation, insufficient capacity and other reasons; " Have participated in other clinical studies.

Sponsors & Collaborators

• Chinese Medical Association: lead

MeSH Terms

Conditions

Shock, Septic; Tachycardia

Interventions

esmolol

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Study Officials

• Wenkui Yu, MD

  The Affliated Drum Tower Hospital, Medical School of Nanjing University

  STUDY CHAIR

Central Study Contacts

Yan Wang, MD

CONTACT

+86-025-83106666-40400; a_nengneng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 25, 2022
• Study Start: July 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: May 25, 2022

Record last verified: 2022-03