Patients With Extracorporeal Membrane OxygenationNCT04963322
The Incidence and Risk Factors of Biliary Complications in Patients With ECMO
An observational study of Patients With Extracorporeal Membrane Oxygenation, run by Kim Hee Young at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Extracorporeal Membrane Oxygenation
- What is being tested?
- extracorporeal membrane oxygenation therapy
- How many people
- 549 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2021to 29 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients over the age of 18 who have received extracorporeal membrane oxygenation therapy
Who may be able to join
- Adult patients over the age of 18 who have received extracorporeal membrane oxygenation therapy
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence and Risk Factors of Biliary Complications in Patients With Extracorporeal Membrane Oxygenation: a Retrospective Observational Study
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.
Read the 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.
- Being tested
- extracorporeal membrane oxygenation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal membrane oxygenation therapyOther
Extracorporeal membrane oxygenation for the management of severe refractory heart and lung dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of biliary tract complications
incidence of biliary tract complications
Measured: during application of ECMO (up to 30 days which is the longest duration for applied ECMO)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start21 May 2021
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim Hee Young
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963322
- Sponsor's protocol ID
- 05-2021-095
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Risk Factors of Biliary Complications in Patients With Extracorporeal Membrane Oxygenation: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT04963322
- Acronym / sponsor ID
- 05-2021-095
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Kim Hee YoungUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 15 Jul 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients over the age of 18 who have received extracorporeal membrane oxygenation therapy
Key inclusion criteria (1 listed)
- Adult patients over the age of 18 who have received extracorporeal membrane oxygenation therapy
Key exclusion criteria (1 listed)
- None.
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 membrane oxygenation therapyExtracorporeal membrane oxygenation for the management of severe refractory heart and lung dysfunction | Other | – |
Primary outcome
incidence of biliary tract complications
Time frame: during application of ECMO (up to 30 days which is the longest duration for applied ECMO)
incidence of biliary tract complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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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.
Hee Young Kim, MD, PhD principal investigator
Pusan National University Yangsan 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 Patients With Extracorporeal Membrane Oxygenation, run by Kim Hee Young at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jul 2021. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of biliary tract complications (time frame: during application of ECMO (up to 30 days which is the longest duration for applied ECMO)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.