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

NCT ID: NCT04032938

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-12-31

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.

Conditions

Sepsis; Cardiopulmonary Bypass

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

the control group

30 healthy people as the control group.

No interventions assigned to this group

the case group

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.

extracorporeal circulation during cardiac surgery

Intervention Type: PROCEDURE

We will observe the cardiopulmonary bypass status and time of patients undergoing cardiac surgery and extracorporeal circulation due to their medical needs.

Interventions

extracorporeal circulation during cardiac surgery

We will observe the cardiopulmonary bypass status and time of patients undergoing cardiac surgery and extracorporeal circulation due to their medical needs.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wenyan Ding

Department of Critical Care Medicine，Doctor in Reading

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Longxiang Su, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenyan Ding, master

Role: CONTACT

muse1yan@163.com

18811152750

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Other Identifiers

ZS-1612

Identifier Type: -

Identifier Source: org_study_id