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Efficacy of Penehyclidine Hydrochloride in Ameliorating Microcirculatory Dysfunction in Patients with Septic Shock: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Efficacy of Penehyclidine Hydrochloride in Ameliorating Microcirculatory Dysfunction in Patients with Septic Shock: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102046
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Septic shock with microcirculation dysfunction

Interventions

Placebo-Control Group:Normal Saline
the experimental group:Penehyclidine Hydrochloride

Sponsors

Hunan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The participants in this study are aged 18 or older. 2. The subjects met the diagnostic criteria for septic shock. Despite achieving the goals of macrocirculatory resuscitation following conventional treatment for septic shock, microcirculatory dysfunction persisted. 3. The participant or their family members provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. The patient is under the age of 18. 2. Pregnant and breastfeeding women; 3. There is a documented case of allergy to penehyclidine hydrochloride or its constituents. 4. Patients with severe cardiovascular diseases (including heart failure classified as NYHA Class III or IV, myocardial infarction), significant arrhythmias that may lead to cardiogenic shock, acute or end-stage liver and kidney failure, hemorrhagic shock, advanced malignant tumors, glaucoma, and dysuria due to benign prostatic hyperplasia were excluded from the study. 5. The patient is experiencing severe septic shock, defined by the presence of any of the following criteria: 1) Persistent or refractory hypotension, characterized by a systolic blood pressure = 8 mmol/L; 3) Requirement for high-dose vasopressors (norepinephrine >= 0.5 µg/kg/min) to maintain blood pressure, or inability to achieve MAP >= 65 mmHg after adequate fluid resuscitation and vasopressor use; 4) Severe organ dysfunction, including but not limited to acute respiratory distress syndrome (ARDS), acute kidney injury (AKI) necessitating renal replacement therapy, acute liver failure, or hepatic encephalopathy. 6. The ISTH score is greater than or equal to five points. 7. Bedside B-ultrasound indicates the presence of severe peripheral artery disease, characterized by arterial lumen stenosis exceeding 50% or complete occlusion. 8. Received treatment with similar pharmacological agents (such as anticholinergic drugs including atropine and scopolamine) within the past week. 9. Patients who have participated in other clinical trials within the past 30 days. 10. Decline the standard therapeutic approach for septic shock; 11. The patient, along with their family members, declined to participate in this study. 12. The researchers posited that additional patients existed who were not suitable for study participation.

Design outcomes

Primary

MeasureTime frame
Peripheral Perfusion Index;Capillary Refill Time;Arterial Blood Lactate Levels;

Secondary

MeasureTime frame
Heart rate;SpO2;

Countries

China

Contacts

Public ContactXiaotong Han

Hunan Provincial People's Hospital

744953695@qq.com+86 731 8392 9129

Outcome results

None listed

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