Multi-omics Study on Gut Microbiota in Critical Ill Patients After Cardiopulmonary Bypass

• Conditions: Sepsis; Cardiopulmonary Bypass
• Interventions: Procedure: extracorporeal circulation during cardiac surgery

• Registration Number: NCT04032938
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Using metagenomics as well as metabolomics, the variation of the gut microbiota and host metabolite profiles of patient after undergoing CPB were explored.

Detailed Description

This protocol is designed as a prospective observational case-control study in patients who underwent cardiopulmonary bypass (CPB) due to cardiac surgery. 30 healthy persons were selected as control group. The case group included patients admitted to intensive care unit (ICU) after cardiac surgery and extracorporeal circulation which is performed by the Department of cardiac surgery of Peking Union Medical College Hospital. The patients enrolled should be divided into two groups according to their primary outcomes: one grouped fever and/or hemodynamic instability after cardiopulmonary bypass and the other grouped normothermia and normal hemodynamic during 48 hours after surgery(cause an infection manifested \>48 hours after admission was defined as hospital acquired. ). Sample collection was terminated when both groups received 30 cases. These 60 cases would regard as the case group. Additionally, all the CPB patients we observed will be divided into survivors and non-survivors based on the 28-day survival. Feces and blood samples will be obtained at certain time points（initial sampling at least one day before the surgery, repeat sampling within 24-48 hours after CPB）. The fecal samples analysis will apply metagenomics and the feces and blood samples will be analyzed using untargeted metabolomics method. In this study, the stratification of gut microbial communities in patients underwent extracorporeal circulation were explored and analysed the variation of metabolite in patients's plasma and fecal samples. Predictive bio-markers and possible pathogenesis of fever and/or hemodynamic instability after CPB will be also provided by clinical outcomes analysis combined with multi-omics study.

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-25
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients will be admitted to ICU between 18 and 85 years of age who will undergo extracorporeal circulation during cardiac surgery and provided written informed consent will be enrolled as candidates of case group.
• Healthy volunteers will be enrolled as control group.

Exclusion Criteria

• Patients had a fever before surgery, regardless of the etiological evidence of infection;
• had anti-infective treatment before surgery;
• had gastrointestinal surgery which left the digestive system dysfunctional;
• had a history of CPB in 6 month;
• reject or abandon ICU therapeutic intervention.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the case group	extracorporeal circulation during cardiac surgery	60 patients were admitted to intensive care unit (ICU) as the case group after cardiac surgery and extracorporeal circulation. This group should contain 30 patients with fever and/or hemodynamic instability and 30 patients with normothermia and normal hemodynamic.

Primary Outcome Measures

Name	Time	Method
Surgery	During sample collection	cardiovascular surgery with cardiopulmonary bypass VS. non-surgery non-surgery is defined as healthy people who don't need surgery.

Secondary Outcome Measures

Name	Time	Method
Anal temperature	within 24-48 hours after cardiopulmonary bypass	Fever VS. non-fever; Definition: Fever: The axillary body temperature is over 38.3℃. Non-fever: The axillary body temperature is below or equal to 38.3℃.
Hemodynamics	within 24-48 hours after cardiopulmonary bypass	Hemodynamic instability VS. normal hemodynamic; Definition: Hemodynamic instability: Vasopressor therapy needed to elevate MAP (mean artarial pressure) ≥65 mmHg.
survival	within 28 days after CPB	survivors vs. non-survivors survivor: Patients survive for 28 days or more after CPB. non-survivors: Patients survive less than 28 days after CPB.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China