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

Recruiting

• Conditions: Sepsis; Septic Shock
• Interventions: Diagnostic Test: gut and nasal microbiota detection

• Registration Number: NCT05143736
• Lead Sponsor: Zhujiang Hospital

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.

Study Timeline

• Study First Submitted: 2021-10-16
• Study First Submitted QC: 2021-11-21
• Study First Posted: 2021-12-03
• Study Start: 2022-01-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Modeling cohort	gut and nasal microbiota detection	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	gut and nasal microbiota detection	The population enrolled at the intensive care unit of Dongguan People's Hospital in Guangdong Province, China will be used as a validation cohort.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (2)

Department of Critical Care Medicine of Zhujiang Hospital; 🇨🇳 Guanzhou, Guangdong, China

Department of Critical Care Medicine of Dongguan People's Hospital, Dongguan; 🇨🇳 Dongguan, Guangdong, China