ClinicalTrials.gg
RecruitingNCT05634057Updated May 21, 2025

Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis

An interventional study of Anisodamine hydrobromide combined with heparin in Sepsis, sponsored by Chen Ying. Recruiting at 1 site in China. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Chen Ying · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
782
Allocation
Randomized
Ages
18 Years to 110 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 285 studies in Sepsis with a site in China — 98 open to participants now, 105 under way, 5 of them phase 3. Sepsis · China.

Planned enrollment
14th of 120
782 · median 119
Started
2024
with 25 others
No phase
66 of 285
27 open now
Primary completion
2025-12
later than 30 of 104 live
Registered
166th of 285
by date

Among the 285 studies in Sepsis with a site in China, this one is the 14th largest by planned enrollment of the 120 interventional ones that give a count, is one of 26 that started in 2024, is one of 66 with no phase, reaches primary completion later than 30 of the 104 other live ones, and was the 166th registered.

Sepsis

2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.

Browse Sepsis studies →

Open to participants now

98 of the 285 studies in Sepsis with a site in China are open now. Recruiting first, the newest first:

93 more — sign in →

All 98 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.

This study: 18 Years to 110 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Sepsis

Browse trials for

04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age greater than 18 years;
  2. Meets the diagnostic criteria for sepsis according to the "Sepsis-3" ;
  3. Patient or their legal representative consents to treatment and signs an form.

Exclusion criteria

Exclusion criteria:

  1. Patients expected to die within 24 hours after enrollment;
  2. to low molecular weight heparin and scopolamine butylbromide drugs;
  3. Patients with thrombotic diseases requiring treatment with low molecular weight heparin;
  4. Patients with terminal-stage , severe immunodeficiency, , severe liver or kidney dysfunction (defined as liver or kidney SOFA score ≥ 3 points), etc.;
  5. Pregnant and lactating women;
  6. Patients participating in other clinical trials.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
782 participants (estimated)

Study arms

  • Experimental
    Anisodamine hydrobromide combined with heparin

    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.

    Drug: Anisodamine hydrobromide combined with heparin

  • No intervention
    conventional therapy

    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.

Interventions

  • DrugAnisodamine hydrobromide combined with heparin

    Drug pages: Anisodamine · Heparin

    The anisodamine hydrobromide combined with heparin treatment group is on the basis of conventional treatment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every patients' survival time will be observed on day 28 after admission.

Secondary outcomes

  1. Lactate clearance rate

    Time frame: The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Dec 2025, 23 months after the start.

Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 23 months is close to that.

Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2022
First posted
Dec 1, 2022
StartActual
Jan 25, 2024
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
May 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05634057
Lead sponsor
Chen Ying
Responsible party
Chen Ying (Research assistant;Junior technician, Beijing Chao Yang Hospital) — Sponsor-investigator
First posted
Dec 1, 2022
Start date
Jan 25, 2024
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 21, 2025

Study contacts

Dong Hongmeng
Contact
donghongmeng@hotmail.com
+8615210511650

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Anisodamine · Heparin

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