Clinical trial NCT05143736: Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Septic Patients
Official title: Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Patients With Sepsis: a Prospective, Multicentered, Diagnostic Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Septic Shock
Keywords: Sepsis
Septic Shock
nasal microbiota
gut microbiota
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this study, patients who met the Sepsis 3.0 diagnostic criteria and with PCT ≥ 2ng/ml and will be recruited.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause death at 28 days
timeFrame: The outcome will be assessed on the 28th day from enrollment
Secondary outcomes:
measure: Incidence of septic shock
timeFrame: The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days
measure: Incidence of persistent inflammation-immunosuppression catabolism syndrome (PICS)
timeFrame: The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Department of Critical Care Medicine of Dongguan People's Hospital, Dongguan
state: Guangdong
city: Guanzhou
country: China
facility: Department of Critical Care Medicine of Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Department of Critical Care Medicine of Zhujiang Hospital
name: Zhanguo Liu, M.D.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan XL, Liu HY, Long J, Jiang Z, Luo Y, Zhao X, Cai S, Zhong X, Cen Z, Su J, Zhou H. Septic patients in the intensive care unit present different nasal microbiotas. Future Microbiol. 2019 Mar;14(5):383-395. doi: 10.2217/fmb-2018-0349. Epub 2019 Feb 26.