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Study on the efficacy and mechanism of pinaverium bromide on sepsis

Study on the efficacy and mechanism of pinaverium bromide on sepsis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043621
Enrollment
Unknown
Registered
2021-02-23
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-22

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

Conditions

sepsis

Interventions

control group:none
Treatment group:PVB pretreatment

Sponsors

Guangdong Provincial Key Laboratory of Proteomics, School of Basic Medical Sciences, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Body temperature is higher than 38.3 degrees C or lower than 36 degees C, there is clear or potential infection; 2. Heart rate is greater than 90 beats/min, or two standard deviations greater than the normal value; 3. Breathing to 20 beats/min or hyperventilation , PaCO2 is greater than 32mmHg; 4. Mental status changes; 5. Obvious edema or positive fluid balance, more than 20ml/Kg in 24 hours; 6. Hyperglycemia and no history of diabetes; 7. Hypotension, systolic blood pressure less than 90mmHg, average pulse pressure less than 70mmHg or adult systolic blood pressure decreased by 40mmHg or two standard deviations lower than the normal value; 8. Leukocytosis (more than 12000/µl); 9. Plasma C-reactive protein and calcitonin are both greater than two standard deviations of normal value; 10. Hypoxemia, the partial pressure of arterial oxygen is less than 300mmHg; 11. Abnormal blood coagulation; 12. Hyperbilirubinemia; 13. Decreased capillary reperfusion capacity or ecchymosis formation; 14. SOFA score greater than or equal to 2 points; 15. Blood content is greater than 1mmol/L; 16. blood creatinine is greater than 44.2µmol.

Exclusion criteria

Exclusion criteria: 1. The number of white blood cells is reduced, less than 4000/µl. 2. Unwilling to participate in the research for various reasons.

Design outcomes

Primary

MeasureTime frame
Changes in NF-?B/MAPK signaling pathway;Changes in calcium ion concentration;Changes in calcium-related kinases;IL-1ß;TNF-a;Bacteria removal ability;

Countries

China

Contacts

Public ContactJinghua Liu

Guangdong Provincial Key Laboratory of Proteomics, School of Basic Medical Sciences, Southern Medical University

liujhua@smu.edu.cn+86 20-61648392

Outcome results

None listed

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