Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Septic Shock, nasal microbiota, gut microbiota
Brief summary
In this prospective, multicentered , diagnostic trial, nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Finally, the characteristics of gut microbiota and nasal microbiota combined clinical information will be used to construct a prediction model to predict the prognosis of sepsis.
Detailed description
Background: Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, with high morbidity and mortality, and its total mortality is 10% to 52%. In sepsis, it is not clear sufficiently about the relationship between intestinal and nasal microbiota character and the development of the sepsis.The study aim to construct a prediction model to predict the prognosis and development of sepsis. Purpose: 1. To construct a prediction model using nasal and gut microbiota combined with clinical events to predict the prognosis of patients with sepsis and development of sepsis. 2. Analyze the characteristics of nasal and gut microbiota in patients with sepsis using microbiology. Methods: nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Meanwhile, some related clinical information also will be collected,including demographic characteristics, comorbidities, infection site, results of the microbiology experiments, vital signs, invasive tubing indwelling at enrollment，combined medication，the requirement of organ function support, laboratory indexing, sequential organ failure assessment score and Acute Physiology and Chronic Health Evaluation score. Finally, the characteristics of gut microbiota and nasal microbiota combined the clinical information will be used to construct a prediction model to predict the prognosis of sepsis. The primary outcome is the 28-day all-cause mortality. The secondary outcomes are the incidence of septic shock, the incidence of persistent inflammation- immunosuppression catabolism syndrome and the 90-day all-cause mortality.
Interventions
DIAGNOSTIC_TESTgut and nasal microbiota detection
The nasal and fecal specimens will be collected by swabs from subjects with sepsis. After that, total DNA of nasal and gut microbiota will be extracted , amplified, and sequenced to determine the gut and nasal microbiota.
Sponsors
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
1. Meet the 2016 International Sepsis Guidelines diagnostic criteria (sepsis 3.0). 2. Serum procalcitonin≥ 2 ng/mL at enrollment.
Exclusion criteria
Patients will be excluded if participants meet any of the following criteria: 1. age\<18 years old or \> 80 years 2. pregnancy or lactation 3. solid organ or bone marrow transplant 4. advanced pulmonary fibrosis 5. HIV-positive 6. neutropenia; 7. hematological/lymphatic tumors have no remission; 8. limited care (lack of commitment to full and aggressive support); 9. long-term use of immunosuppressive drugs or immunodeficiency; 10. advanced tumors; 11. combined with noninfectious factors leading to death (uncontrolled large bleeding, cerebral hernia, etc.); 12. Combined with autoimmune diseases 13. Paraquat poisoning 14. Combined with Nasopharyngeal carcinoma 15. Combined with chronic nasosinusitis 16. Combined with severe nasal injuries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death at 28 days | The outcome will be assessed on the 28th day from enrollment | All-cause mortality from the enrollment to the 28th day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of septic shock | The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days | Incidence of septic shock during the ICU stay. |
| Incidence of persistent inflammation-immunosuppression catabolism syndrome (PICS) | The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days | The incidence of PICS during the ICU stay. Patients who meet all the following diagnostic criteria will be diagnosed PICS: 1) the duration of ICU stay more than 14 days, 2) the level of serum C reactive protein \> 50ug/dL, 3) Lymphocyte counts\<0.80\*10\^9/L,4) serum albumin\<3g/dL, 5) serum prealbumin\<10mg/dL, 6) The creatinine height index\<80%. 7)weight loss more than 18% or BMI\<18 |
Countries
China
Contacts
Primary ContactZhanguo Liu, M.D.PhD
Backup ContactXilan Tan, M.D.PhD
Outcome results
None listed