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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05389176
• Other study ID #: 2022-038-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2022
• Source: Chinese Medical Association
• Contact: Yan Wang, MD
• Phone: +86-025-83106666-40400
• Email: a_nengneng[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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; " ß-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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic
• Tachycardia

Intervention

Drug:
• Esmolol
a continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	cardiac index	PiCCO monitoring parameters	at 24-hour after randomization
Secondary	cardiac index	PiCCO monitoring parameters	at 48-hour after randomization
Secondary	cardiac index	PiCCO monitoring parameters	at 72-hour after randomization
Secondary	cardiac index	PiCCO monitoring parameters	at 96-hour after randomization
Secondary	ejection fraction	cardiac measurement by cardiac ultrasound	at 24-hour after randomization
Secondary	ejection fraction	cardiac measurement by cardiac ultrasound	at 48-hour after randomization
Secondary	ejection fraction	cardiac measurement by cardiac ultrasound	at 72-hour after randomization
Secondary	ejection fraction	cardiac measurement by cardiac ultrasound	at 96-hour after randomization
Secondary	Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 24-hour after randomization
Secondary	Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 48-hour after randomization
Secondary	Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 72-hour after randomization
Secondary	Arterial blood PH value	Arterial blood PH value by arterial blood gas analysis	at 96-hour after randomization
Secondary	Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 24-hour after randomization
Secondary	Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 48-hour after randomization
Secondary	Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 72-hour after randomization
Secondary	Arterial blood lactate	Arterial blood lactate by arterial blood gas analysis	at 96-hour after randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	SOFA scores	sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.	at 24-hour after randomization
Secondary	SOFA scores	sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.	at 48-hour after randomization
Secondary	SOFA scores	sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.	at 72-hour after randomization
Secondary	SOFA scores	sepsis-related organ failure assessment score,value 4~24, the higher score means worse outcome.	at 96-hour after randomization
Secondary	norepinephrine dose	norepinephrine dose (ug/kg.min)	at 24-hour after randomization
Secondary	norepinephrine dose	norepinephrine dose (ug/kg.min)	at 48-hour after randomization
Secondary	norepinephrine dose	norepinephrine dose (ug/kg.min)	at 72-hour after randomization
Secondary	norepinephrine dose	norepinephrine dose (ug/kg.min)	at 96-hour after randomization
Secondary	ICU- free days (by 28 days)	days free of ICU	from randomization until 28 days
Secondary	28-day mortality	28-day mortality	from randomization until 28 days
Secondary	days of mechanical ventilation	days of mechanical ventilation	from randomization until 28 days
Secondary	the incidence of hypotension deteriorated	the incidence of hypotension deteriorated	by 96-hour after randomization
Secondary	the incidence of heart arrest	the incidence of heart arrest	by 96-hour after randomization