The Incidence and Risk Factors of Biliary Complications in Patients With ECMO

Completed

• Conditions: Patients With Extracorporeal Membrane Oxygenation

• Registration Number: NCT04963322
• Lead Sponsor: Kim Hee Young

Brief Summary

By confirming the incidence of biliary tract complications in adult patients aged 18 years or older who received extracorporeal membrane oxygenation , and measuring the duration of application of extracorporeal membrane oxygenation, drugs administered during the application period of extracorporeal membrane oxygenation, duration of fasting period, duration of total intravenous nutrition, and plasma bilirubin concentration, the researchers will try to find risk factors of biliary tract complications in patients receiving extracorporeal membrane oxygenation. Clinically, the researchers will check whether there are modifiable risk factors in patients receiving extracorporeal membrane oxygenation.

Detailed Description

Extracorporeal membrane oxygenation is an important method for the management of severe refractory heart and lung dysfunction, and improvements in extracorporeal membrane oxygenation equipment and increased experience have made it possible to use it for a long time. However, complications following extracorporeal membrane oxygenation are very common, and mortality and morbidity are high. When extracorporeal membrane oxygenation is applied, gastrointestinal bleeding may occur due to stress, ischemia, or bleeding tendency, and direct secondary bilirubin elevation and gallstone formation may occur secondary to long-term fasting, total intravenous nutrition, hemolysis, and diuretics. In intensive care patients, acalculous cholecystitis can progress with multiple organ failure and is known to be associated with prolonged ICU stay and high mortality. However, there is no report on whether the incidence of cholecystitis, risk factors, direct elevation of bilirubin, and cholelithiasis in patients receiving extracorporeal membrane oxygenation progresses to symptomatic cholecystitis.

Study Timeline

• Study Start: 2021-05-21
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Study First Submitted: 2021-06-29
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 549

Inclusion Criteria

• Adult patients over the age of 18 who have received extracorporeal membrane oxygenation therapy

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of biliary tract complications	during application of ECMO (up to 30 days which is the longest duration for applied ECMO)	incidence of biliary tract complications

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of