SepsisNCT04537767
The Effect of Esmolol on Patients With Sepsis
A study testing Esmolol in people with Sepsis, run by Shanghai Zhongshan Hospital.
Trial summary
The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 30 Sep 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sepsis patients
- HR>100bpm 6h after admission
- with CVC and ScvO2>65%
Who cannot join
- age <18 years,
- used β-blocker before,
- cardiac dysrhythmias,
- need for an inotropic agent,
- valvular heart disease,
- hemoglobin>6g/L
- pregnancy.
About this study
The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.
Read the detailed description
Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.
- Conditions
- Sepsis
- Being tested
- Esmolol, Placebo
- Keywords
- sepsis, septic shock, esmolol
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
The protocol required a titrated esmolol infusion commenced at 25 mg/ h, with an upper dose limit of 2000 mg/h, to maintain the HR between 75 and 90 bpm in ES group. The control group were treated with placebo.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ES group | Experimental | Patients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range. Receives: Drug: Esmolol |
| control group | Placebo comparator | Patients randomly assigned to the control group were treated with placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
REE
Resting energy expenditure
Measured: Day 7 after enrollment
Secondary outcomes (5)
28-day mortality rate
28-day mortality rate
Measured: Day 28 after enrollment
HR control rate
target heart rate control rate
Measured: 24 hours after enrollment
Vasoactive drug administration dose
Vasoactive drug administration dose
Measured: Day 1/3/7 after enrollment
Concentration of Lac
Concentration of lactic acid
Measured: Day 1/3/7 after enrollment
O2ER
oxygen extraction rate
Measured: Day 1/3/7 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537767
- Sponsor's protocol ID
- ES-01
- Status last verified
- Aug 2020
- First submitted
- 14 Jun 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esmolol on Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04537767
- Acronym / sponsor ID
- ES-01
- Conditions
- Sepsis
- Keywords
- sepsis, septic shock, esmolol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 3 Sep 2020 (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.
The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.
Detailed description
Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES group | Experimental | Drug: EsmololPatients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range. |
| control group | Placebo comparator | Drug: PlaceboPatients randomly assigned to the control group were treated with placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sepsis patients
- HR>100bpm 6h after admission
- with CVC and ScvO2>65%
Key exclusion criteria (7 listed)
- age <18 years,
- used β-blocker before,
- cardiac dysrhythmias,
- need for an inotropic agent,
- valvular heart disease,
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 |
|---|---|---|
| EsmololThe protocol required a titrated esmolol infusion commenced at 25 mg/ h, with an upper dose limit of 2000 mg/h, to maintain the HR between 75 and 90 bpm in ES group. The control group were treated with placebo. | Drug | ES group |
| PlaceboPlacebo | Drug | control group |
Primary outcome
REE
Time frame: Day 7 after enrollment
Resting energy expenditure
5 secondary outcomes
28-day mortality rate
Time frame: Day 28 after enrollment
HR control rate
Time frame: 24 hours after enrollment
Vasoactive drug administration dose
Time frame: Day 1/3/7 after enrollment
Concentration of Lac
Time frame: Day 1/3/7 after enrollment
O2ER
Time frame: Day 1/3/7 after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Esmolol in people with Sepsis, run by Shanghai Zhongshan Hospital.
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 3 inclusion and 7 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 3 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REE (time frame: Day 7 after enrollment). 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 3 Sep 2020.