SepsisNCT05634057
Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
A study testing Anisodamine hydrobromide combined with heparin in people with Sepsis, run by Chen Ying at 1 site in China.
Trial summary
The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Anisodamine hydrobromide combined with heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 782 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years;
- Meets the diagnostic criteria for sepsis according to the "Sepsis-3" ;
- Patient or their legal representative consents to treatment and signs an informed consent form.
Who cannot join
- Patients expected to die within 24 hours after enrollment;
- Contraindications to low molecular weight heparin and scopolamine butylbromide drugs;
- Patients with thrombotic diseases requiring treatment with low molecular weight heparin;
- Patients with terminal-stage malignancies, severe immunodeficiency, immunosuppression, severe liver or kidney dysfunction (defined as liver or kidney SOFA score ≥ 3 points), etc.;
- Pregnant and lactating women;
- Patients participating in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China, 100020
Dong Hongmeng, +8615210511650, donghongmeng@hotmail.com
About this study
Official title: Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
Read the detailed description
Objective: The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically infected patients requiring vasopressor use. The critically infected patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.
Interim analysis will be performed. The primary study end point is 28-day mortality, and other secondary study endpoint is lactate clearance rate. The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental groups and the control group.
Discussion: The treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. The study will provide new insight into the treatment of patients with critical infection and can help to reduce mortality rate of critically infected patients.
- Conditions
- Sepsis
- Being tested
- Anisodamine hydrobromide combined with heparin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anisodamine hydrobromide combined with heparinDrug
The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Anisodamine hydrobromide combined with heparin | Experimental | Anisodamine hydrobromide injection + low molecular weight heparin + basic treatment: The dosage of scopolamine butylbromide is 2.0mg/(kg*d), administered via a micro-pump at a constant rate, continuously for 3 days. The dosage range for low molecular weight heparin is limited to 3000-6000U, administered subcutaneously once daily, continuously for 3 days. Receives: Drug: Anisodamine hydrobromide combined with heparin |
| conventional therapy | No intervention | Conventional treatment includes shock treatment, eliminating the cause of the condition, actively treating the primary disease, replenishing blood volume, correcting acid-base imbalances, using vasoactive drugs to maintain blood pressure, and advanced life support as needed, such as the use of a ventilator and bedside blood filtration for organ support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
The patients will be followed up for 28 days, as our usual hospital length of stay for critically infected patients is 28 days. The investigators will recorded the specific time of death.
Measured: Every patients' survival time will be observed on day 28 after admission.
Secondary outcomes (1)
Lactate clearance rate
Measured: The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start25 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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.
- 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
- Model description
- The SEPSIS patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 782 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Ying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Ying, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634057
- Sponsor's protocol ID
- Z211100002921061
- Status last verified
- May 2025
- First submitted
- 9 Nov 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
- ClinicalTrials.gov ID
- NCT05634057
- Acronym / sponsor ID
- Z211100002921061
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 782 participants (estimated)
- Lead sponsor
- Chen YingUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Dec 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.
The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
Detailed description
Objective: The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically infected patients requiring vasopressor use. The critically infected patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.
Interim analysis will be performed. The primary study end point is 28-day mortality, and other secondary study endpoint is lactate clearance rate. The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental groups and the control group.
Discussion: The treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. The study will provide new insight into the treatment of patients with critical infection and can help to reduce mortality rate of critically infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The SEPSIS patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.
| Arm | Type | Receives |
|---|---|---|
| Anisodamine hydrobromide combined with heparin | Experimental | Drug: Anisodamine hydrobromide combined with heparinAnisodamine hydrobromide injection + low molecular weight heparin + basic treatment: The dosage of scopolamine butylbromide is 2.0mg/(kg*d), administered via a micro-pump at a constant rate, continuously for 3 days. The dosage range for low molecular weight heparin is limited to 3000-6000U, administered subcutaneously once daily, continuously for 3 days. |
| conventional therapy | No intervention | –Conventional treatment includes shock treatment, eliminating the cause of the condition, actively treating the primary disease, replenishing blood volume, correcting acid-base imbalances, using vasoactive drugs to maintain blood pressure, and advanced life support as needed, such as the use of a ventilator and bedside blood filtration for organ support. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years;
- Meets the diagnostic criteria for sepsis according to the "Sepsis-3" ;
- Patient or their legal representative consents to treatment and signs an informed consent form.
Key exclusion criteria (6 listed)
- Patients expected to die within 24 hours after enrollment;
- Contraindications to low molecular weight heparin and scopolamine butylbromide drugs;
- Patients with thrombotic diseases requiring treatment with low molecular weight heparin;
- Patients with terminal-stage malignancies, severe immunodeficiency, immunosuppression, severe liver or kidney dysfunction (defined as liver or kidney SOFA score ≥ 3 points), etc.;
- Pregnant and lactating women;
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 |
|---|---|---|
| Anisodamine hydrobromide combined with heparinThe anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment. | Drug | Anisodamine hydrobromide combined with heparin |
Primary outcome
28-day mortality
Time frame: Every patients' survival time will be observed on day 28 after admission.
The patients will be followed up for 28 days, as our usual hospital length of stay for critically infected patients is 28 days. The investigators will recorded the specific time of death.
1 secondary outcome
Lactate clearance rate
Time frame: The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anisodamine hydrobromide combined with heparin in people with Sepsis, run by Chen Ying at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Hongmeng (+8615210511650, donghongmeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: Every patients' survival time will be observed on day 28 after admission.). 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 21 May 2025.