Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Septic Patients

Sepsis Clinical Trial

Official title:

Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Patients With Sepsis: a Prospective, Multicentered, Diagnostic Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143736
• Other study ID #: 2021-KY-108-01
• Status: Recruiting
• Start date: January 10, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Zhujiang Hospital
• Contact: Zhanguo Liu, M.D.PhD
• Phone: +86-2062782927
• Email: zhguoliu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock, Septic

Intervention

Diagnostic Test:
• gut 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.

Locations

Country	Name	City	State
China	Department of Critical Care Medicine of Dongguan People's Hospital, Dongguan	Dongguan	Guangdong
China	Department of Critical Care Medicine of Zhujiang Hospital	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of septic shock	Incidence of septic shock during the ICU stay.	The outcome will be assessed diurnally until ICU discharge,the longest evaluation duration is no more than 28 days
Secondary	Incidence of persistent inflammation-immunosuppression catabolism syndrome (PICS)	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	The outcome will be assessed diurnally until ICU discharge,the longest evaluation duration is no more than 28 days

External Links

•   The related background of this study