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Using metagenomics as well as metabolomics, the variation of the gut microbiota and host metabolite profiles of patient after undergoing CPB were explored.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extracorporeal circulation during cardiac surgery | Procedure | We will observe the cardiopulmonary bypass status and time of patients undergoing cardiac surgery and extracorporeal circulation due to their medical needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery | cardiovascular surgery with cardiopulmonary bypass VS. non-surgery non-surgery is defined as healthy people who don't need surgery. | During sample collection |
| Measure | Description | Time Frame |
|---|---|---|
| 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℃. | within 24-48 hours after cardiopulmonary bypass |
| Hemodynamics |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenyan Ding, master | Contact | 18811152750 | muse1yan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Longxiang Su, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11717024 | Background | 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. | |
| 31227375 | Background | Ariyaratnam 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. |
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After the trial is completed, we may publish the IPD in the paper.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Feces and blood samples will be obtained and stored at -80℃.
Hemodynamic instability VS. normal hemodynamic
Definition:
Hemodynamic instability: Vasopressor therapy needed to elevate MAP (mean artarial pressure) ≥65 mmHg.
| 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. | within 28 days after CPB |
| 25061221 | Background | Gorski 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. |
| 30552885 | Background | Wang 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. |
| Background | A. F. Ueber peritoneale infection. Wien Klin Wochenschr. 1891;4:241, 265, 285. |
| 27670109 | Background | 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. |
| 29232157 | Background | Singer 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. |
| 26715502 | Background | Ojima 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. |
| 28546562 | Background | Kim 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. |
| 30052920 | Background | Czesnikiewicz-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. |
| 41166145 | Derived | Ding 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. |
| 32733902 | Derived | Ding 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |