Clinical trial NCT04032938: Multi-omics Study on Gut Microbiota in Critical Ill Patients After Cardiopulmonary Bypass
Official title: Clinical and Multi-omics Study on Gut Microbiota in Critical Ill Patients After Cardiovascular Surgery Combined Cardiopulmonary Bypass With or Without Sepsis（CPB-MUL-GM Study): a Prospective Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Cardiopulmonary Bypass
Keywords: Cardiopulmonary Bypass
Gastrointestinal Microbiome
Thoracic Surgery
Metagenomics
Metabolomics
sepsis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 healthy volunteers will be randomly selected as the control group.

Patients enrolled in the case group underwent cardiac surgery combined with extracorporeal circulation for medical reasons.

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.

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.

Primary outcomes:
measure: Surgery
timeFrame: During sample collection
Secondary outcomes:
measure: Anal temperature
timeFrame: within 24-48 hours after cardiopulmonary bypass
measure: Hemodynamics
timeFrame: within 24-48 hours after cardiopulmonary bypass
measure: survival
timeFrame: within 28 days after CPB
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Longxiang Su, MD
role: PRINCIPAL_INVESTIGATOR
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