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

Sepsis Clinical Trial

— CPB-MUL-GM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032938
• Other study ID #: ZS-1612
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: Wenyan Ding, master
• Phone: 18811152750
• Email: muse1yan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Sepsis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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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 May 27. pii: S1053-0770(19)30497-5. doi: 10.1053/j.jvca.2019.05.034. [Epub ahead of print] — View Citation

Czesnikiewicz-Guzik M, Müller 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. — View Citation

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. — View Citation

Gorski A, Hamouda K, Özkur 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. — View Citation

Kim D, Zeng MY, Núñez 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery	cardiovascular surgery with cardiopulmonary bypass VS. non-surgery non-surgery is defined as healthy people who don't need surgery.	During sample collection
Secondary	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
Secondary	Hemodynamics	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
Secondary	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