Sepsis, Septic Shock
Conditions
Keywords
Digital Droplet PCR, Etiology Diagnose
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 crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures may represent a promising alternative. In particular, droplet digital PCR (ddPCR) is a novel one-step PCR assay that achieves higher accuracy and sensitivity in detecting causing pathogens in patients with bloodstream infections.
Interventions
DIAGNOSTIC_TESTdroplet digital PCR method
The droplet digital PCR method can detect nucleic acids from the most common pathogens (approximately 90%) responsible for BSIs according to Chinet2020 and takes about 4 hours to perform, reporting within the first 24h of suspected sepsis/septic shock.
DIAGNOSTIC_TESTblood culture
Blood culture is a conventional microbiological method of pathogen detection. Results from blood cultures are usually not available until 24 to 72 hours after sampling.
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.18 years or older 2.Meet 2 of 4 sepsis criteria 1. Temperature \> 38C or \< 36C 2. Heart rate \> 90 bpm 3. Respiratory rate \>20 or PaCO2 \<32mmHg 4. WBC \>12000/µL or \< 4000/µL or \> 10% bands 3.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis 4.Informed Consent by patient or legal representative.
Exclusion criteria
1. Refusal to participate in the study or Failure to comply with treatment or follow-up time 2. Known breastfeeding or pregnancy 3. 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 4. Participating in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | Up to 96 hours post blood collection | The primary endpoint of estimated specificity will be determined by comparing negative blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens. |
| Sensitivity | Up to 96 hours post blood collection | The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with targeted antimicrobial therapy | Up to the end of study participation, an average of 1 year | — |
| Time to identification of a potential pathogen | At time point of identification of a potential pathogen, up to 96 hours post blood collection | — |
| Change in condition severity | Up to the end of study participation, an average of 1 year | The sequential organ failure assessment score (SOFA score), previously known as the sepsis-related organ failure assessment score, higher scores mean worse outcome. |
| Days in intensive care unit (ICU) | Up to the end of study participation, an average of 1 year | — |
| Duration of antimicrobials | Up to the end of study participation, an average of 1 year | — |
| Days in hospital (from study inclusion) | Up to the end of study participation, an average of 1 year | — |
| All-cause death | Up to the end of study participation, an average of 1 year | — |
| Treatment costs | Up to the end of study participation, an average of 1 year | — |
| Quality of life of survivors after being discharged | Up to the end of study participation, an average of 1 year | EQ-5D, a standardised measure of health-related quality of life developed by the EuroQol Group.The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The number of levels in these dimensions is 5 in the EQ-5D-5L. Higher levels mean worse health states. |
| Ventilation duration in ICU (hours) | Up to the end of study participation, an average of 1 year | — |
| Time to the change to the targeted antimicrobial therapy | At time point of change to the targeted antimicrobial therapy, up to 96 hours post blood collection | — |
Countries
China
Outcome results
None listed