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Clinical study on the efficacy and safety of anisodamine hydrobromide injection in the treatment of septic shock

Clinical study on the efficacy and safety of anisodamine hydrobromide injection in the treatment of septic shock

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110719
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock

Interventions

Case Group:None
Control group:None

Sponsors

The First People's Hospital of Lianyungang City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients clinically diagnosed with septic shock; 2. Age: 18-80 years old, gender not limited; 3. Subjects whose 28-day survival status can be obtained through hospital electronic medical records and other means; 4. Those who have been diagnosed with septic shock and whose maximum blood lactate value is greater than 2mmol/L within 48 hours and have started treatment; 5.For patients in the anisodamine hydrobromide injection group, the maximum daily dosage should not be less than 40mg, and the cumulative dosage should not be less than 80mg.

Exclusion criteria

Exclusion criteria: 1. During hospitalization, the combined use of the following drugs may confuse the evaluation of drug efficacy: atropine, racemic scopolamine; 2. Patients with combined malignant tumors; 3. Patients with combined granulocytopenia; 4. Patients with cardiogenic shock, obstructive shock, and hypovolemic shock; 5. Immunosuppressive patients: Patients who continue to use immunosuppressants.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
7-day all-cause mortality;Blood lactate clearance rate;Blood lactate clearance;Hospital mortality;Sequential Organ Failure Assessment (SOFA);Usage of vasoactive drugs within 7 days;Hemodynamic parameters;Blood indicators: blood routine, blood gas analysis, renal function, liver function, brain natriuretic peptide, infection indicators;Glasgow Coma Scale (GCS;Acute Physiological score;Age score;Chronic Health Evaluation II (APACHE II;Multiple Organ Dysfunction Score (MODS;Acute Gastrointestinal Injury Grading Score (AGI) score;

Countries

China

Contacts

Public ContactKang Xiuwen

The First People's Hospital of Lianyungang City

mafei8922@163.com+86 518 8576 7073

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026