SepsisCPB-MUL-GMNCT04032938
Multi-omics Study on Gut Microbiota in Critical Ill Patients After Cardiopulmonary Bypass
An observational study of Sepsis and Cardiopulmonary Bypass, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Using metagenomics as well as metabolomics, the variation of the gut microbiota and host metabolite profiles of patient after undergoing CPB were explored. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Cardiopulmonary Bypass
- What is being tested?
- extracorporeal circulation during cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Longxiang Su, MD
Wenyan Ding, Master
About this study
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
Using metagenomics as well as metabolomics, the variation of the gut microbiota and host metabolite profiles of patient after undergoing CPB were explored.
Read the 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
- Being tested
- extracorporeal circulation during cardiac surgery
- Keywords
- Cardiopulmonary Bypass, Gastrointestinal Microbiome, Thoracic Surgery, Metagenomics, Metabolomics, sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal circulation during cardiac surgeryProcedure or surgery
We will observe the cardiopulmonary bypass status and time of patients undergoing cardiac surgery and extracorporeal circulation due to their medical needs.
| Study group | Role | What they receive |
|---|---|---|
| the control group | 30 healthy people as the control 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. Receives: Procedure: extracorporeal circulation during cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery
cardiovascular surgery with cardiopulmonary bypass VS. non-surgery non-surgery is defined as healthy people who don't need surgery.
Measured: During sample collection
Secondary outcomes (3)
Anal temperature
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℃.
Measured: within 24-48 hours after cardiopulmonary bypass
Hemodynamics
Hemodynamic instability VS. normal hemodynamic
Definition:
Hemodynamic instability: Vasopressor therapy needed to elevate MAP (mean artarial pressure) ≥65 mmHg.
Measured: within 24-48 hours after cardiopulmonary bypass
survival
survivors vs. non-survivors survivor: Patients survive for 28 days or more after CPB. non-survivors: Patients survive less than 28 days after CPB.
Measured: within 28 days after CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Aug 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenyan Ding, Peking Union Medical College Hospital
- Investigators
- Longxiang Su, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032938
- Sponsor's protocol ID
- ZS-1612
- Acronym
- CPB-MUL-GM
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the trial is completed, we may publish the IPD in the paper.
Publications
Sergeant P, de Worm E, Meyns B. Single centre, single domain validation of the EuroSCORE on a consecutive sample of primary and repeat CABG. Eur J Cardiothorac Surg. 2001 Dec;20(6):1176-82. doi: 10.1016/s1010-7940(01)01013-2.
PubMed 11717024Ariyaratnam P, Ananthasayanam A, Moore J, Vijayan A, Hong V, Loubani M. Prediction of Postoperative Outcomes and Long-Term Survival in Cardiac Surgical Patients Using the Intensive Care National Audit & Research Centre Score. J Cardiothorac Vasc Anesth. 2019 Nov;33(11):3022-3027. doi: 10.1053/j.jvca.2019.05.034. Epub 2019 May 27.
PubMed 31227375Gorski A, Hamouda K, Ozkur M, Leistner M, Sommer SP, Leyh R, Schimmer C. Cardiac surgery antibiotic prophylaxis and calculated empiric antibiotic therapy. Asian Cardiovasc Thorac Ann. 2015 Mar;23(3):282-8. doi: 10.1177/0218492314546028. Epub 2014 Jul 24.
PubMed 25061221Wang YC, Wu HY, Luo CY, Lin TW. Cardiopulmonary Bypass Time Predicts Early Postoperative Enterobacteriaceae Bloodstream Infection. Ann Thorac Surg. 2019 May;107(5):1333-1341. doi: 10.1016/j.athoracsur.2018.11.020. Epub 2018 Dec 12.
PubMed 30552885A. F. Ueber peritoneale infection. Wien Klin Wochenschr. 1891;4:241, 265, 285.
Dickson RP, Singer BH, Newstead MW, Falkowski NR, Erb-Downward JR, Standiford TJ, Huffnagle GB. Enrichment of the lung microbiome with gut bacteria in sepsis and the acute respiratory distress syndrome. Nat Microbiol. 2016 Jul 18;1(10):16113. doi: 10.1038/nmicrobiol.2016.113.
PubMed 27670109Singer BH, Dickson RP, Denstaedt SJ, Newstead MW, Kim K, Falkowski NR, Erb-Downward JR, Schmidt TM, Huffnagle GB, Standiford TJ. Bacterial Dissemination to the Brain in Sepsis. Am J Respir Crit Care Med. 2018 Mar 15;197(6):747-756. doi: 10.1164/rccm.201708-1559OC.
PubMed 29232157Ojima M, Motooka D, Shimizu K, Gotoh K, Shintani A, Yoshiya K, Nakamura S, Ogura H, Iida T, Shimazu T. Metagenomic Analysis Reveals Dynamic Changes of Whole Gut Microbiota in the Acute Phase of Intensive Care Unit Patients. Dig Dis Sci. 2016 Jun;61(6):1628-34. doi: 10.1007/s10620-015-4011-3. Epub 2015 Dec 29.
PubMed 26715502Kim D, Zeng MY, Nunez G. The interplay between host immune cells and gut microbiota in chronic inflammatory diseases. Exp Mol Med. 2017 May 26;49(5):e339. doi: 10.1038/emm.2017.24.
PubMed 28546562Czesnikiewicz-Guzik M, Muller DN. Scientists on the Spot: Salt, the microbiome, and cardiovascular diseases. Cardiovasc Res. 2018 Aug 1;114(10):e72-e73. doi: 10.1093/cvr/cvy171. No abstract available.
PubMed 30052920Ding W, Zhang H, Wen J, Xiong G, Cheng M, Liu J, Zhao Y, Miao Q, Deng H, Xu Z, Mi L, Tan Z, Su L, Long Y, Ning K. A Multiomics Analysis Reveals a Gut Microbiome: LPC Metabolic Axis Driving Postoperative Inflammation in Cardiopulmonary Bypass Patients. Shock. 2026 Feb 1;65(2):188-200. doi: 10.1097/SHK.0000000000002722. Epub 2025 Sep 17.
PubMed 41166145Ding W, Liu J, Zhou X, Miao Q, Zheng H, Zhou B, Dou G, Tong Y, Long Y, Su L. Clinical Multi-Omics Study on the Gut Microbiota in Critically Ill Patients After Cardiovascular Surgery Combined With Cardiopulmonary Bypass With or Without Sepsis (MUL-GM-CSCPB Study): A Prospective Study Protocol. Front Med (Lausanne). 2020 Jul 8;7:269. doi: 10.3389/fmed.2020.00269. eCollection 2020.
PubMed 32733902
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04032938
- Acronym / sponsor ID
- CPB-MUL-GM / ZS-1612
- Conditions
- Sepsis, Cardiopulmonary Bypass
- Keywords
- Cardiopulmonary Bypass, Gastrointestinal Microbiome, Thoracic Surgery, Metagenomics, Metabolomics, sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | – | –30 healthy people as the control group. |
| the case group | – | Procedure: extracorporeal circulation during cardiac surgery60 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal circulation during cardiac surgeryWe will observe the cardiopulmonary bypass status and time of patients undergoing cardiac surgery and extracorporeal circulation due to their medical needs. | Procedure or surgery | the case group |
Primary outcome
Surgery
Time frame: During sample collection
cardiovascular surgery with cardiopulmonary bypass VS. non-surgery non-surgery is defined as healthy people who don't need surgery.
3 secondary outcomes
Anal temperature
Time frame: within 24-48 hours after cardiopulmonary bypass
Hemodynamics
Time frame: within 24-48 hours after cardiopulmonary bypass
survival
Time frame: within 28 days after CPB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 11717024Sergeant P, de Worm E, Meyns B. Single centre, single domain validation of the EuroSCORE on a consecutive sample of primary and repeat CABG. Eur J Cardiothorac Surg. 2001 Dec;20(6):1176-82. doi: 10.1016/s1010-7940(01)01013-2.
- Background: PubMed 31227375Ariyaratnam P, Ananthasayanam A, Moore J, Vijayan A, Hong V, Loubani M. Prediction of Postoperative Outcomes and Long-Term Survival in Cardiac Surgical Patients Using the Intensive Care National Audit & Research Centre Score. J Cardiothorac Vasc Anesth. 2019 Nov;33(11):3022-3027. doi: 10.1053/j.jvca.2019.05.034. Epub 2019 May 27.
- Background: PubMed 25061221Gorski A, Hamouda K, Ozkur M, Leistner M, Sommer SP, Leyh R, Schimmer C. Cardiac surgery antibiotic prophylaxis and calculated empiric antibiotic therapy. Asian Cardiovasc Thorac Ann. 2015 Mar;23(3):282-8. doi: 10.1177/0218492314546028. Epub 2014 Jul 24.
- Background: PubMed 30552885Wang YC, Wu HY, Luo CY, Lin TW. Cardiopulmonary Bypass Time Predicts Early Postoperative Enterobacteriaceae Bloodstream Infection. Ann Thorac Surg. 2019 May;107(5):1333-1341. doi: 10.1016/j.athoracsur.2018.11.020. Epub 2018 Dec 12.
- BackgroundA. F. Ueber peritoneale infection. Wien Klin Wochenschr. 1891;4:241, 265, 285.
- Background: PubMed 27670109Dickson RP, Singer BH, Newstead MW, Falkowski NR, Erb-Downward JR, Standiford TJ, Huffnagle GB. Enrichment of the lung microbiome with gut bacteria in sepsis and the acute respiratory distress syndrome. Nat Microbiol. 2016 Jul 18;1(10):16113. doi: 10.1038/nmicrobiol.2016.113.
- Background: PubMed 29232157Singer BH, Dickson RP, Denstaedt SJ, Newstead MW, Kim K, Falkowski NR, Erb-Downward JR, Schmidt TM, Huffnagle GB, Standiford TJ. Bacterial Dissemination to the Brain in Sepsis. Am J Respir Crit Care Med. 2018 Mar 15;197(6):747-756. doi: 10.1164/rccm.201708-1559OC.
- Background: PubMed 26715502Ojima M, Motooka D, Shimizu K, Gotoh K, Shintani A, Yoshiya K, Nakamura S, Ogura H, Iida T, Shimazu T. Metagenomic Analysis Reveals Dynamic Changes of Whole Gut Microbiota in the Acute Phase of Intensive Care Unit Patients. Dig Dis Sci. 2016 Jun;61(6):1628-34. doi: 10.1007/s10620-015-4011-3. Epub 2015 Dec 29.
- Background: PubMed 28546562Kim D, Zeng MY, Nunez G. The interplay between host immune cells and gut microbiota in chronic inflammatory diseases. Exp Mol Med. 2017 May 26;49(5):e339. doi: 10.1038/emm.2017.24.
- Background: PubMed 30052920Czesnikiewicz-Guzik M, Muller DN. Scientists on the Spot: Salt, the microbiome, and cardiovascular diseases. Cardiovasc Res. 2018 Aug 1;114(10):e72-e73. doi: 10.1093/cvr/cvy171. No abstract available.
- Derived from this study: PubMed 41166145Ding W, Zhang H, Wen J, Xiong G, Cheng M, Liu J, Zhao Y, Miao Q, Deng H, Xu Z, Mi L, Tan Z, Su L, Long Y, Ning K. A Multiomics Analysis Reveals a Gut Microbiome: LPC Metabolic Axis Driving Postoperative Inflammation in Cardiopulmonary Bypass Patients. Shock. 2026 Feb 1;65(2):188-200. doi: 10.1097/SHK.0000000000002722. Epub 2025 Sep 17.
- Derived from this study: PubMed 32733902Ding W, Liu J, Zhou X, Miao Q, Zheng H, Zhou B, Dou G, Tong Y, Long Y, Su L. Clinical Multi-Omics Study on the Gut Microbiota in Critically Ill Patients After Cardiovascular Surgery Combined With Cardiopulmonary Bypass With or Without Sepsis (MUL-GM-CSCPB Study): A Prospective Study Protocol. Front Med (Lausanne). 2020 Jul 8;7:269. doi: 10.3389/fmed.2020.00269. eCollection 2020.
- Individual participant dataSharing planned: Undecided. After the trial is completed, we may publish the IPD in the paper.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Longxiang Su, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Cardiopulmonary Bypass, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenyan Ding, master (18811152750, muse1yan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery (time frame: During sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032938, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.