Study on gut microbiota and metabolomics in patients with sepsis and ARDS

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300078188

Enrollment

Unknown

Registered

2023-11-30

Start date

2023-12-01

Completion date

Unknown

Last updated

2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis, ARDS

Interventions

Sepsis with ARDS group:None

Control group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult healthy volunteers and sepsis patients aged = 18 years old 2. Patients with sepsis combined with ARDS: Sepsis related sequential organ failure score (SOFA) = 2, with a clear site of infection. Simultaneously meeting the diagnosis of ARDS 1. Inducing factors: induced by various acute triggering factors such as pneumonia, extrapulmonary infection, trauma, aspiration, shock, blood transfusion, etc; 2. Origin of pulmonary edema: The cause of pulmonary edema should exclude pulmonary edema mainly caused by cardiogenic and fluid overload, as well as hypoxemia mainly caused by atelectasis; 3. Acute respiratory failure or worsening of respiratory failure occurs within one week after the occurrence of the triggering factor; 4. Chest X-ray or chest CT shows bilateral exudate shadows, or chest ultrasound (with well trained operators) indicates bilateral B-line or consolidation signs; 5. Oxygenation: (1) Non tracheal intubation ARDS: Based on the use of high flow oxygen therapy (flow rate = 30L/min) or NIV/CPAP with PEEP = 5cmH2O, PaO2/FiO2 = 300 mmHg or SpO2/FiO2 = 315 (SpO2 = 97%). (2) Endotracheal intubation mechanical ventilation ARDS: a. Mild: 200<PaO2/FiO2 = 300 or 235 = SpO2/FiO2 = 315 (if SpO2 = 97%); b. Moderate: 100<PaO2/FiO2 = 200 or 148<SpO2/FiO2 = 235 (if SpO2 = 97%); c. Severe: PaO2/FiO2 = 100 or SpO2/FiO2 = 148 (if SpO2 = 97%). The diagnosis is ARDS.

Exclusion criteria

Exclusion criteria: 1. Refuse the test. 2. Concomitant with other respiratory system diseases, such as bronchial asthma, chronic obstructive pulmonary disease, pulmonary nodules, pulmonary interstitial fibrosis, and other causes of ARDS or a history of lung surgery. 3. Patients with intestinal fistula. 4. Pregnant and lactating women. 5. Incomplete data collection due to any reason Cases that meet any of the above criteria are not included in this study.

Design outcomes

Primary

Measure	Time frame
metabolomics;Intestinal flora;Infection indicators;	—

Countries

China

Contacts

Public ContactZhengshang Ruan

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

ruanzhengshang@xinhuamed.com.cn+86 21 2507 7825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026