Clinical trial NCT04963322: The Incidence and Risk Factors of Biliary Complications in Patients With ECMO
Official title: The Incidence and Risk Factors of Biliary Complications in Patients With Extracorporeal Membrane Oxygenation: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Extracorporeal Membrane Oxygenation
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients over the age of 18 who have received extracorporeal membrane oxygenation therapy

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: incidence of biliary tract complications
timeFrame: during application of ECMO (up to 30 days which is the longest duration for applied ECMO)
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Hee Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: