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

NCT ID: NCT05389176

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-06-30

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.

Detailed Description

The incidence of septic shock complicated with tachycardia is high and the prognosis is poor. Enough attention should be paid to and appropriate treatment should be given. High heart rate and high cardiac output are beneficial compensatory reactions of sepsis and septic shock. However, excessive sympathetic activation and high heart rate also have adverse effects on the cardiovascular system. Sustained tachycardia is harmful to patients with sepsis and septic shock and needs to be controlled. At present, it is widely used in the treatment of cardiovascular diseases and β Receptor blockers have the functions of preventing and reversing sympathetic effects, anti arrhythmia, anti-inflammatory and balancing myocardial oxygen supply and demand. Therefore, they are recommended to control arrhythmias in patients with septic shock. The 2014 guidelines for sepsis / septic shock in China suggest that if cardiac output is not low and the heart rate is fast after adequate fluid resuscitation, short acting drugs（β Receptor blockers）can be considered. However, there are some differences in the current clinical research results, and it suggests that the timing of treatment may affect the hemodynamic results and clinical outcomes of patients.

Therefore, this study intends to intervene with esmolol in patients with septic shock and tachycardia at different stages, and compare the hemodynamic parameters, clinical outcome, prognosis and adverse reactions with the conventional treatment group, in order to explore the appropriate time of esmolol in the treatment of patients with septic shock and tachycardia.

Conditions

Septic Shock; Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Esmolol

Intervention Type: DRUG

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

Group B

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

Group Type: EXPERIMENTAL

Esmolol

Intervention Type: DRUG

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

Group C

patients received conventional therapy in accordance with septic shock guidelines 2021

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Esmolol

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

Intervention Type: DRUG

Other Intervention Names

β-receptor blockers

Eligibility Criteria

Inclusion Criteria

" ≥ 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.

Exclusion Criteria

" 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenkui Yu, MD

Role: STUDY_CHAIR

The Affliated Drum Tower Hospital, Medical School of Nanjing University

Central Contacts

Yan Wang, MD

Role: CONTACT

a_nengneng@163.com

+86-025-83106666-40400

Other Identifiers

2022-038-02

Identifier Type: -

Identifier Source: org_study_id