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Efficacy and safety of anisodamine hydrobromide injection in sepsis: a prospective, open, randomized, controlled, multicenter clinical study

Efficacy and safety of anisodamine hydrobromide injection in sepsis: a prospective, open, randomized, controlled, multicenter clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063969
Enrollment
Unknown
Registered
2022-09-22
Start date
2022-09-22
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Sepsis

Interventions

Experimental group:Anisodamine hydrobromide injection
Control group:None

Sponsors

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed as sepsis (infection +sofa score >= 2 points) [containing septic shock (vasoconstrictors are still required after full volume resuscitation to maintain the mean arterial pressure >= 65 mmHg, lactic acid >2mmol/l)]; 2. Aged >= 18 years, no gender limit; 3. Obtain the informed consent and signature of the patient or guardian.

Exclusion criteria

Exclusion criteria: 1. Poor prognosis, such as severe craniocerebral injury, cardiopulmonary resuscitation, advanced malignant tumors, and severe chronic diseases of various systems; 2. Patients with immunosuppression, excluding patients with continued immunosuppressive use; 3. Patients with granulocytosis; 4. Patients with increased intracranial pressure, acute stage of cerebral hemorrhage and glaucoma; 5. Allergic constitution, history of drug or food allergy or known allergy to the components of this medicine; 6. Patients who are pregnant or have a pregnancy plan and are lactating; 7. Have participated in other clinical trials in the last 3 months; 8. Patients with mental diseases who cannot cooperate with normal test procedures; 9. Other reasons considered by the researchers not to be included.

Design outcomes

Primary

MeasureTime frame
28 day all-cause mortality;7-day patient profile;Stay time in ICU;Length of patient stay;Capillary refill time;24-hour lactate clearance;Glasgow coma scale score;Acute physiological score + age score + chronic health score;Sepsis-related sequential organ failure score;Number of days of use of ventilator and renal replacement therapy;Conversion rate of sepsis progression to septic shock;General conditions (heart rate, body temperature, blood pressure);Use of vasoactive drugs (norepinephrine, dopamine);

Secondary

MeasureTime frame
Central venous pressure;Inflammatory markers (IL-6, IL-10);Sublingual microcirculation monitoring;Mean arterial pressure (MAP);Central venous oxygen saturation (ScvO2);Blood routine (WBC?NE?LY?HCT?PLT);Blood gas (pH, partial pressure of oxygen, partial pressure of carbon dioxide, alkali surplus, oxygenation index);Renal function (BUN, Cr);Brain natriuretic peptide (BNP);Infection indicator (PCT);Liver (AST, GGT, ALP, DBiL, GLU, ALB);Cardiac indicators (Myo, CTNI, CK-MB);Electrolytes (K, Na, Ca, Mg);Coagulation (INR, TT, APTT, fbg, D-Dimer);Etiological results;

Countries

China

Contacts

Public ContactZhou Ping
zp_319@163.com+86 18981838176

Outcome results

None listed

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