Status:
COMPLETED
Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
Lead Sponsor:
Huashan Hospital
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sepsis is a significant public health concern worldwide, with high morbidity and mortality. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of c...
Eligibility Criteria
Inclusion
- 18 years or older
- Meet 2 of 4 sepsis criteria
- Temperature \> 38C or \< 36C
- Heart rate \> 90 bpm
- Respiratory rate \>20 or PaCO2 \<32mmHg
- WBC \>12000/µL or \< 4000/µL or \> 10% bands
- Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis
- Informed Consent by patient or legal representative.
Exclusion
- Refusal to participate in the study or Failure to comply with treatment or follow-up time
- Known breastfeeding or pregnancy
- The researcher believes that there are any conditions (social or medical) that allow subjects to participate is unsafe. For example, severe anemia or high risk of bleeding,etc., which are not suitable for taking peripheral blood for testing
- Participating in other clinical studies
Key Trial Info
Start Date :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT05190861
Start Date
December 29 2021
End Date
December 29 2023
Last Update
July 11 2025
Active Locations (9)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
Xiangya Hospital Central South University
Changsha, Hunan, China, 410013
3
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China, 210001
4
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, China, 214016