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

Chinese Medical Association96 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Septic Shock Tachycardia

Interventions

EsmololDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: at 24-hour after randomization

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

Time frame: at 48-hour after randomization

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

Time frame: at 72-hour after randomization

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

Time frame: at 96-hour after randomization

Secondary Outcomes

cardiac index

PiCCO monitoring parameters

Time frame: at 24-hour after randomization

cardiac index

PiCCO monitoring parameters

Time frame: at 48-hour after randomization

cardiac index

PiCCO monitoring parameters

Time frame: at 72-hour after randomization

cardiac index

PiCCO monitoring parameters

Time frame: at 96-hour after randomization

ejection fraction

Central Contacts

Yan Wang, MD

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

cardiac measurement by cardiac ultrasound

Time frame: at 24-hour after randomization

ejection fraction

cardiac measurement by cardiac ultrasound

Time frame: at 48-hour after randomization

ejection fraction

cardiac measurement by cardiac ultrasound

Time frame: at 72-hour after randomization

ejection fraction

cardiac measurement by cardiac ultrasound

Time frame: at 96-hour after randomization

Arterial blood PH value

Arterial blood PH value by arterial blood gas analysis

Time frame: at 24-hour after randomization

Arterial blood PH value

Arterial blood PH value by arterial blood gas analysis

Time frame: at 48-hour after randomization

Arterial blood PH value

Arterial blood PH value by arterial blood gas analysis

Time frame: at 72-hour after randomization

Arterial blood PH value

Arterial blood PH value by arterial blood gas analysis

Time frame: at 96-hour after randomization

Arterial blood lactate

Arterial blood lactate by arterial blood gas analysis

Time frame: at 24-hour after randomization

Arterial blood lactate

Arterial blood lactate by arterial blood gas analysis

Time frame: at 48-hour after randomization

Arterial blood lactate

Arterial blood lactate by arterial blood gas analysis

Time frame: at 72-hour after randomization

Arterial blood lactate

Arterial blood lactate by arterial blood gas analysis

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: at 96-hour after randomization

SOFA scores

sepsis-related organ failure assessment score，value 4\~24, the higher score means worse outcome.

Time frame: at 24-hour after randomization

SOFA scores

sepsis-related organ failure assessment score，value 4\~24, the higher score means worse outcome.

Time frame: at 48-hour after randomization

SOFA scores

sepsis-related organ failure assessment score，value 4\~24, the higher score means worse outcome.

Time frame: at 72-hour after randomization

SOFA scores

sepsis-related organ failure assessment score，value 4\~24, the higher score means worse outcome.

Time frame: at 96-hour after randomization

norepinephrine dose

norepinephrine dose (ug/kg.min)

Time frame: at 24-hour after randomization

norepinephrine dose

norepinephrine dose (ug/kg.min)

Time frame: at 48-hour after randomization

norepinephrine dose

norepinephrine dose (ug/kg.min)

Time frame: at 72-hour after randomization

norepinephrine dose

norepinephrine dose (ug/kg.min)

Time frame: at 96-hour after randomization

ICU- free days (by 28 days)

days free of ICU

Time frame: from randomization until 28 days

28-day mortality

Time frame: from randomization until 28 days

days of mechanical ventilation

Time frame: from randomization until 28 days

the incidence of hypotension deteriorated

Time frame: by 96-hour after randomization

the incidence of heart arrest

Time frame: by 96-hour after randomization