Septic ShockNCT05389176
Effects of Heart Control at Different Stages in Patients of Septic Shock With Tachycardia
A study testing Esmolol in people with Septic Shock and Tachycardia, run by Chinese Medical Association.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Tachycardia
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- " ≥ 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.
Who cannot join
- " 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Esmolol
- Keywords
- Septic Shock, Tachycardia, β receptor blockers
- Medical subject headings
- Shock, Septic, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Also called β-receptor blockers
a continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Esmolol is used 6 to 24 hours after onset of septic shock in patients with fluid optimization to control heart beats between 70-100bpm. Receives: Drug: Esmolol |
| Group B | Experimental | Esmolol is used 24 hours after onset of septic shock in patients to control heart beats between 70-100bpm. Receives: Drug: Esmolol |
| Group C | No intervention | patients received conventional therapy in accordance with septic shock guidelines 2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with heart rate of 70-100 bpm
the proportion of patients with heart rate of 70-100 bpm
Measured: 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
Measured: 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
Measured: 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
Measured: at 96-hour after randomization
Secondary outcomes (33)
cardiac index
PiCCO monitoring parameters
Measured: at 24-hour after randomization
cardiac index
PiCCO monitoring parameters
Measured: at 48-hour after randomization
cardiac index
PiCCO monitoring parameters
Measured: at 72-hour after randomization
cardiac index
PiCCO monitoring parameters
Measured: at 96-hour after randomization
ejection fraction
cardiac measurement by cardiac ultrasound
Measured: at 24-hour after randomization
ejection fraction
cardiac measurement by cardiac ultrasound
Measured: at 48-hour after randomization
ejection fraction
cardiac measurement by cardiac ultrasound
Measured: at 72-hour after randomization
ejection fraction
cardiac measurement by cardiac ultrasound
Measured: at 96-hour after randomization
Arterial blood PH value
Arterial blood PH value by arterial blood gas analysis
Measured: at 24-hour after randomization
Arterial blood PH value
Arterial blood PH value by arterial blood gas analysis
Measured: at 48-hour after randomization
Arterial blood PH value
Arterial blood PH value by arterial blood gas analysis
Measured: at 72-hour after randomization
Arterial blood PH value
Arterial blood PH value by arterial blood gas analysis
Measured: at 96-hour after randomization
Arterial blood lactate
Arterial blood lactate by arterial blood gas analysis
Measured: at 24-hour after randomization
Arterial blood lactate
Arterial blood lactate by arterial blood gas analysis
Measured: at 48-hour after randomization
Arterial blood lactate
Arterial blood lactate by arterial blood gas analysis
Measured: at 72-hour after randomization
Arterial blood lactate
Arterial blood lactate by arterial blood gas analysis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 96-hour after randomization
SOFA scores
sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.
Measured: at 24-hour after randomization
SOFA scores
sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.
Measured: at 48-hour after randomization
SOFA scores
sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.
Measured: at 72-hour after randomization
SOFA scores
sepsis-related organ failure assessment score，value 4~24, the higher score means worse outcome.
Measured: at 96-hour after randomization
norepinephrine dose
norepinephrine dose (ug/kg.min)
Measured: at 24-hour after randomization
norepinephrine dose
norepinephrine dose (ug/kg.min)
Measured: at 48-hour after randomization
norepinephrine dose
norepinephrine dose (ug/kg.min)
Measured: at 72-hour after randomization
norepinephrine dose
norepinephrine dose (ug/kg.min)
Measured: at 96-hour after randomization
ICU- free days (by 28 days)
days free of ICU
Measured: from randomization until 28 days
28-day mortality
28-day mortality
Measured: from randomization until 28 days
days of mechanical ventilation
days of mechanical ventilation
Measured: from randomization until 28 days
the incidence of hypotension deteriorated
the incidence of hypotension deteriorated
Measured: by 96-hour after randomization
the incidence of heart arrest
the incidence of heart arrest
Measured: by 96-hour after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Wenkui Yu, MD, Study chair, The Affliated Drum Tower Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389176
- Sponsor's protocol ID
- 2022-038-02
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heart Control at Different Stages on Hemodynamics Parameters and Clinical Prognosis in Patients of Septic Shock With Tachycardia
- ClinicalTrials.gov ID
- NCT05389176
- Acronym / sponsor ID
- 2022-038-02
- Conditions
- Septic Shock, Tachycardia
- Keywords
- Septic Shock, Tachycardia, β receptor blockers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: EsmololEsmolol is used 6 to 24 hours after onset of septic shock in patients with fluid optimization to control heart beats between 70-100bpm. |
| Group B | Experimental | Drug: EsmololEsmolol is used 24 hours after onset of septic shock in patients to control heart beats between 70-100bpm. |
| Group C | No intervention | –patients received conventional therapy in accordance with septic shock guidelines 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- " ≥ 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.
Key exclusion criteria (1 listed)
- " 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsmololAlso: β-receptor blockersa continuous esmolol infusion titrated to maintain heart rate between 70/min and 100/min | Drug | Group A, Group B |
Primary outcome
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
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
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
the proportion of patients with heart rate of 70-100 bpm
Time frame: at 96-hour after randomization
the proportion of patients with heart rate of 70-100 bpm
33 secondary outcomes
cardiac index
Time frame: at 24-hour after randomization
cardiac index
Time frame: at 48-hour after randomization
cardiac index
Time frame: at 72-hour after randomization
cardiac index
Time frame: at 96-hour after randomization
ejection fraction
Time frame: at 24-hour after randomization
ejection fraction
Time frame: at 48-hour after randomization
ejection fraction
Time frame: at 72-hour after randomization
ejection fraction
Time frame: at 96-hour after randomization
Arterial blood PH value
Time frame: at 24-hour after randomization
Arterial blood PH value
Time frame: at 48-hour after randomization
Arterial blood PH value
Time frame: at 72-hour after randomization
Arterial blood PH value
Time frame: at 96-hour after randomization
Arterial blood lactate
Time frame: at 24-hour after randomization
Arterial blood lactate
Time frame: at 48-hour after randomization
Arterial blood lactate
Time frame: at 72-hour after randomization
Arterial blood lactate
Time frame: at 96-hour after randomization
APACHEII scores
Time frame: at 24-hour after randomization
APACHEII scores
Time frame: at 48-hour after randomization
APACHEII scores
Time frame: at 72-hour after randomization
APACHEII scores
Time frame: at 96-hour after randomization
SOFA scores
Time frame: at 24-hour after randomization
SOFA scores
Time frame: at 48-hour after randomization
SOFA scores
Time frame: at 72-hour after randomization
SOFA scores
Time frame: at 96-hour after randomization
norepinephrine dose
Time frame: at 24-hour after randomization
norepinephrine dose
Time frame: at 48-hour after randomization
norepinephrine dose
Time frame: at 72-hour after randomization
norepinephrine dose
Time frame: at 96-hour after randomization
ICU- free days (by 28 days)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenkui Yu, MD study chair
The Affliated Drum Tower Hospital, Medical School of Nanjing University
Questions about this trial
What is this clinical trial studying?
A study testing Esmolol in people with Septic Shock and Tachycardia, run by Chinese Medical Association.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, MD (+86-025-83106666-40400, a_nengneng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients with heart rate of 70-100 bpm (time frame: at 24-hour after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.