Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Septic Patients
1 other identifier
observational
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2021
CompletedFirst Posted
Study publicly available on registry
December 3, 2021
CompletedStudy Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedMarch 19, 2024
January 1, 2024
3 years
October 16, 2021
March 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause death at 28 days
All-cause mortality from the enrollment to the 28th day
The outcome will be assessed on the 28th day from enrollment
Secondary Outcomes (2)
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 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
Study Arms (2)
Modeling cohort
The population enrolled at the intensive care unit of Zhujiang Hospital of Southern Medical University in Guangdong Province, China will be used as a modeling cohort.For the patients in this cohort, the nasal and fecal specimens and related clinical information will collected to construct the prediction model.
validation cohort
The population enrolled at the intensive care unit of Dongguan People's Hospital in Guangdong Province, China will be used as a validation cohort.
Interventions
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.
Eligibility Criteria
In this study, patients who met the Sepsis 3.0 diagnostic criteria and with PCT ≥ 2ng/ml and will be recruited.
You may qualify if:
- Meet the 2016 International Sepsis Guidelines diagnostic criteria (sepsis 3.0).
- Serum procalcitonin≥ 2 ng/mL at enrollment.
You may not qualify if:
- Patients will be excluded if participants meet any of the following criteria:
- age\<18 years old or \> 80 years
- pregnancy or lactation
- solid organ or bone marrow transplant
- advanced pulmonary fibrosis
- HIV-positive
- neutropenia;
- hematological/lymphatic tumors have no remission;
- limited care (lack of commitment to full and aggressive support);
- long-term use of immunosuppressive drugs or immunodeficiency;
- advanced tumors;
- combined with noninfectious factors leading to death (uncontrolled large bleeding, cerebral hernia, etc.);
- Combined with autoimmune diseases
- Paraquat poisoning
- Combined with Nasopharyngeal carcinoma
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Critical Care Medicine of Dongguan People's Hospital, Dongguan
Dongguan, Guangdong, China
Department of Critical Care Medicine of Zhujiang Hospital
Guanzhou, Guangdong, China
Related Publications (1)
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.
PMID: 30803270BACKGROUND
Biospecimen
Total DNA of nasal and gut microbiota coming from patients with sepsis will be extracted , amplified, and sequenced.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanguo Liu, M.D.PhD
Department of Critical Care Medicine of Zhujiang Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director of Critical Care Medicine, Principal Investigator
Study Record Dates
First Submitted
October 16, 2021
First Posted
December 3, 2021
Study Start
January 10, 2022
Primary Completion
December 31, 2024
Study Completion
January 31, 2025
Last Updated
March 19, 2024
Record last verified: 2024-01