Septic Shock, Tachycardia
Conditions
Keywords
Septic Shock, Tachycardia, β receptor blockers
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.
Interventions
DRUGEsmolol
a continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min
Sponsors
Chinese Medical Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ejection fraction | at 24-hour after randomization | cardiac measurement by cardiac ultrasound |
| Arterial blood PH value | at 24-hour after randomization | Arterial blood PH value by arterial blood gas analysis |
| Arterial blood lactate | at 24-hour after randomization | Arterial blood lactate by arterial blood gas analysis |
| APACHEII scores | at 24-hour after randomization | the Acute Physiology and Chronic Health Evaluation II scores，value 0～60, the higher score means worse outcome. |
| SOFA scores | at 24-hour after randomization | sepsis-related organ failure assessment score，value 4\ 24, the higher score means worse outcome. |
| cardiac index | at 24-hour after randomization | PiCCO monitoring parameters |
| ICU- free days (by 28 days) | from randomization until 28 days | days free of ICU |
| 28-day mortality | from randomization until 28 days | 28-day mortality |
| days of mechanical ventilation | from randomization until 28 days | days of mechanical ventilation |
| the incidence of hypotension deteriorated | by 96-hour after randomization | the incidence of hypotension deteriorated |
| the incidence of heart arrest | by 96-hour after randomization | the incidence of heart arrest |
| norepinephrine dose | at 24-hour after randomization | norepinephrine dose (ug/kg.min) |
Contacts
Primary ContactYan Wang, MD
Outcome results
None listed