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

Effects of Heart Control at Different Stages on Hemodynamics Parameters and Clinical Prognosis in Patients of Septic Shock With Tachycardia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock; Tachycardia
• Intervention / Treatment: Drug: Esmolol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Wang, MD; Phone Number: +86-025-83106666-40400; Email: a_nengneng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Esmolol; a continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min; Other Names: β-receptor blockers
EXPERIMENTAL: Group B; Esmolol is used 24 hours after onset of septic shock in patients to control heart beats between 70-100bpm.	Drug: Esmolol; a continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min; Other Names: β-receptor blockers
NO_INTERVENTION: Group C; patients received conventional therapy in accordance with septic shock guidelines 2021

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac index	PiCCO monitoring parameters	at 24-hour after randomization
cardiac index	PiCCO monitoring parameters	at 48-hour after randomization
cardiac index	PiCCO monitoring parameters	at 72-hour after randomization
cardiac index	PiCCO monitoring parameters	at 96-hour after randomization
ejection fraction	cardiac measurement by cardiac ultrasound	at 24-hour after randomization
ejection fraction	cardiac measurement by cardiac ultrasound	at 48-hour after randomization
ejection fraction	cardiac measurement by cardiac ultrasound	at 72-hour after randomization
ejection fraction	cardiac measurement by cardiac ultrasound	at 96-hour after randomization
Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 24-hour after randomization
Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 48-hour after randomization
Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 72-hour after randomization
Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 96-hour after randomization
Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 24-hour after randomization
Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 48-hour after randomization
Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 72-hour after randomization
Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 96-hour after randomization
APACHEII scores	the Acute Physiology and Chronic Health Evaluation II scores，value 0～60, the higher score means worse outcome.	at 24-hour after randomization
APACHEII scores	the Acute Physiology and Chronic Health Evaluation II scores，value 0~60, the higher score means worse outcome.	at 48-hour after randomization
APACHEII scores	the Acute Physiology and Chronic Health Evaluation II scores，value 0~60, the higher score means worse outcome.	at 72-hour after randomization
APACHEII scores	the Acute Physiology and Chronic Health Evaluation II scores，value 0~60, the higher score means worse outcome.	at 96-hour after randomization
SOFA scores	sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.	at 24-hour after randomization
SOFA scores	sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.	at 48-hour after randomization
SOFA scores	sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.	at 72-hour after randomization
SOFA scores	sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.	at 96-hour after randomization
norepinephrine dose	norepinephrine dose (ug/kg.min)	at 24-hour after randomization
norepinephrine dose	norepinephrine dose (ug/kg.min)	at 48-hour after randomization
norepinephrine dose	norepinephrine dose (ug/kg.min)	at 72-hour after randomization
norepinephrine dose	norepinephrine dose (ug/kg.min)	at 96-hour after randomization
ICU- free days (by 28 days)	days free of ICU	from randomization until 28 days
28-day mortality	28-day mortality	from randomization until 28 days
days of mechanical ventilation	days of mechanical ventilation	from randomization until 28 days
the incidence of hypotension deteriorated	the incidence of hypotension deteriorated	by 96-hour after randomization
the incidence of heart arrest	the incidence of heart arrest	by 96-hour after randomization

Collaborators and Investigators

• Sponsor: Chinese Medical Association

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): March 31, 2024
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (ACTUAL): May 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Septic Shock; Tachycardia; β receptor blockers
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Shock, Septic; Shock; Tachycardia; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-1 Receptor Antagonists; Esmolol
• Other Study ID Numbers: 2022-038-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No