Acute Lung InjuryNCT01922557
Thoracic Fluid Content and Acute Lung Injury
An observational study of Acute Lung Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To study the association of the thoracic fluid content and acute lung injury during liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- NICOM
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Jun 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: end stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital were enrolled.
Who may be able to join
- end stage liver disease scheduled for liver transplantation in National Taiwna University Hospital.
Who cannot join
- allergic reaction
- history of aortic regurgitation
- pre-existing pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Thoracic Fluid Content and Acute Lung Injury in Liver Transplantation
To study the association of the thoracic fluid content and acute lung injury during liver transplantation.
Read the detailed description
Acute lung injury is not uncommon after liver transplantation. A new monitor non-invasive cardiac output monitor (NICOM) is designed to measure thoracic fluid content. The investigators attempt to use the parameter thoracic fluid content to investigate its relationship with acute lung injury in liver transplant recipients.
- Conditions
- Acute Lung Injury
- Being tested
- NICOM
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICOMDevice
NICOM monitoring thoracic fluid content at baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4).
| Study group | Role | What they receive |
|---|---|---|
| NICOM | Not described Receives: Device: NICOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index
Participants will be followed for the duration the operation. Cardiac index was measured by non-invasive cardiac output monitor at different time points as baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4)
Measured: one day
Secondary outcomes (1)
Thoracic fluid content
Participants will be followed for the duration the operation.Thoracic fluid content was measured in liver transplant recipients at different time points as baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4).
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang Cheng Chan, M.D., Principal investigator, Department of Anesthesiology, NTUH, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922557
- Sponsor's protocol ID
- 201012081RC
- Status last verified
- Aug 2013
- First submitted
- 11 Jul 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
Publications
Hong SK, Hwang S, Lee SG, Lee LS, Ahn CS, Kim KH, Moon DB, Ha TY. Pulmonary complications following adult liver transplantation. Transplant Proc. 2006 Nov;38(9):2979-81. doi: 10.1016/j.transproceed.2006.08.090.
PubMed 17112879
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Thoracic Fluid Content and Acute Lung Injury in Liver Transplantation
- ClinicalTrials.gov ID
- NCT01922557
- Acronym / sponsor ID
- 201012081RC
- Conditions
- Acute Lung Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Aug 2013 (estimated)
- 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.
To study the association of the thoracic fluid content and acute lung injury during liver transplantation.
Detailed description
Acute lung injury is not uncommon after liver transplantation. A new monitor non-invasive cardiac output monitor (NICOM) is designed to measure thoracic fluid content. The investigators attempt to use the parameter thoracic fluid content to investigate its relationship with acute lung injury in liver transplant recipients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NICOM | – | Device: NICOM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- end stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital were enrolled.
Key inclusion criteria (1 listed)
- end stage liver disease scheduled for liver transplantation in National Taiwna University Hospital.
Key exclusion criteria (3 listed)
- allergic reaction
- history of aortic regurgitation
- pre-existing pulmonary disease
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 |
|---|---|---|
| NICOMNICOM monitoring thoracic fluid content at baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4). | Device | NICOM |
Primary outcome
Cardiac index
Time frame: one day
Participants will be followed for the duration the operation. Cardiac index was measured by non-invasive cardiac output monitor at different time points as baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4)
1 secondary outcome
Thoracic fluid content
Time frame: one day
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 14 Aug 2013.
- Background: PubMed 17112879Hong SK, Hwang S, Lee SG, Lee LS, Ahn CS, Kim KH, Moon DB, Ha TY. Pulmonary complications following adult liver transplantation. Transplant Proc. 2006 Nov;38(9):2979-81. doi: 10.1016/j.transproceed.2006.08.090.
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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.
Kuang Cheng Chan, M.D. principal investigator
Department of Anesthesiology, NTUH, Taipei, Taiwan
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 Acute Lung Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 14 Aug 2013. 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 Taiwan. 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?
Cardiac index (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922557, which also lists 1 linked publication.
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 14 Aug 2013.