Liver TransplantationNCT04261816
Early Extubation and Postoperative Complications After Liver Transplantation
An observational study of Liver Transplantation, run by West China Hospital at 1 site in China.
Trial summary
This is a retrospective cohort study. Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study and divided into two groups. Operating room extubation group: early extubation in the operating room immediately following liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- extubation in the operating room and extubation in the ICU
- Type of treatment
- Surgery or procedure
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2020to 15 Apr 2020
- 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: Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study.
Who may be able to join
- Adult patients (age ≥ 18 years)
- Undergoing liver transplantation
Who cannot join
- Re-transplantation
- Multi-organ transplants
- Intra-operative deaths
- severe encephalopathy (West Haven criteria III or IV)
- patients who had preoperative mechanical ventilation or fulminant hepatic failure
- Incomplete clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Early Extubation and Postoperative Complications After Liver Transplantation: A Retrospective Propensity Score-matched Analysis
This is a retrospective cohort study. Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study and divided into two groups. Operating room extubation group: early extubation in the operating room immediately following liver transplantation. Intensive care unit (ICU) extubation group: delay extubation in the ICU following liver transplantation. The primary objectives were to compare the incidence of composite outcome between the two groups. secondary objectives were to compare outcomes such as length of stay, hospital length of stay, and total cost between the two groups.
Read the detailed description
Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study. Inclusion criteria: (1) adult patients (age ≥ 18 years), (2) undergoing liver transplantation. Exclusion criteria were the following: (1) re-transplantation; (2) multi-visceral transplantation; (3) intraoperative death; (4) severe encephalopathy (West Haven criteria III or IV); (5) those who had preoperative mechanical ventilation; (6) incomplete clinical data. The primary objectives was a composite of 30-day all-cause mortality, in-hospital AKI, or in-hospital moderate to severe pulmonary complications. Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery. The secondary objectives included in-hospital moderate to severe infectious complications, unplanned reintubation rates, ICU and postoperative hospital lengths of stay, and total hospital cost.
- Conditions
- Liver Transplantation
- Being tested
- extubation in the operating room, extubation in the ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extubation in the operating roomProcedure or surgery
Patients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation
extubation in the ICUProcedure or surgery
Patients who underwent liver transplantation extubation in the ICU following liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Operating room extubation group | extubation in the operating room immediately following liver transplantation Receives: Procedure: extubation in the operating room | |
| ICU extubation group | extubation in the ICU following liver transplantation Receives: Procedure: extubation in the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications.
Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
The incidence of moderate to severe infectious complications
Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery
Measured: 30 days
The incidence of re-intubation.
Reintubation was defined as intubation after extubation of a patient who had been initially tracheal intubated under general anaesthesia
Measured: 30 days
The length of hospital stay
Length of hospital stay is the duration of a single episode of hospitalization
Measured: through study completion, an average of 1 year
The length of ICU stay
Length of ICU stay is the duration of a single episode of ICU hospitalization
Measured: through study completion, an average of 1 year
The total hospital cost
The total hospital cost
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start15 Jan 2020
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
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 Liver TransplantationStudies of the same condition, open and under way.
- More trials run by West China 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261816
- Sponsor's protocol ID
- 2020-014
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu Y, Zuo Y, Zhou L, Hao X, Xiao X, Ye M, Bo L, Jiang C, Yang J. Extubation in the operating room results in fewer composite mechanical ventilation-related adverse outcomes in patients after liver transplantation: a retrospective cohort study. BMC Anesthesiol. 2021 Nov 18;21(1):286. doi: 10.1186/s12871-021-01508-1.
PubMed 34794387
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Extubation and Postoperative Complications After Liver Transplantation: A Retrospective Propensity Score-matched Analysis
- ClinicalTrials.gov ID
- NCT04261816
- Acronym / sponsor ID
- 2020-014
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 10 Feb 2020 (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.
This is a retrospective cohort study. Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study and divided into two groups. Operating room extubation group: early extubation in the operating room immediately following liver transplantation. Intensive care unit (ICU) extubation group: delay extubation in the ICU following liver transplantation. The primary objectives were to compare the incidence of composite outcome between the two groups. secondary objectives were to compare outcomes such as length of stay, hospital length of stay, and total cost between the two groups.
Detailed description
Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study. Inclusion criteria: (1) adult patients (age ≥ 18 years), (2) undergoing liver transplantation. Exclusion criteria were the following: (1) re-transplantation; (2) multi-visceral transplantation; (3) intraoperative death; (4) severe encephalopathy (West Haven criteria III or IV); (5) those who had preoperative mechanical ventilation; (6) incomplete clinical data. The primary objectives was a composite of 30-day all-cause mortality, in-hospital AKI, or in-hospital moderate to severe pulmonary complications. Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery. The secondary objectives included in-hospital moderate to severe infectious complications, unplanned reintubation rates, ICU and postoperative hospital lengths of stay, and total hospital cost.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operating room extubation group | – | Procedure: extubation in the operating roomextubation in the operating room immediately following liver transplantation |
| ICU extubation group | – | Procedure: extubation in the ICUextubation in the ICU following liver transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study.
Key inclusion criteria (2 listed)
- Adult patients (age ≥ 18 years)
- Undergoing liver transplantation
Key exclusion criteria (6 listed)
- Re-transplantation
- Multi-organ transplants
- Intra-operative deaths
- severe encephalopathy (West Haven criteria III or IV)
- patients who had preoperative mechanical ventilation or fulminant hepatic failure
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 |
|---|---|---|
| extubation in the operating roomPatients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation | Procedure or surgery | Operating room extubation group |
| extubation in the ICUPatients who underwent liver transplantation extubation in the ICU following liver transplantation | Procedure or surgery | ICU extubation group |
Primary outcome
The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications.
Time frame: through study completion, an average of 1 year
Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery
5 secondary outcomes
The incidence of moderate to severe infectious complications
Time frame: 30 days
The incidence of re-intubation.
Time frame: 30 days
The length of hospital stay
Time frame: through study completion, an average of 1 year
The length of ICU stay
Time frame: through study completion, an average of 1 year
The total hospital cost
Time frame: 30 days
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 10 Jun 2021.
- Derived from this study: PubMed 34794387Xu Y, Zuo Y, Zhou L, Hao X, Xiao X, Ye M, Bo L, Jiang C, Yang J. Extubation in the operating room results in fewer composite mechanical ventilation-related adverse outcomes in patients after liver transplantation: a retrospective cohort study. BMC Anesthesiol. 2021 Nov 18;21(1):286. doi: 10.1186/s12871-021-01508-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Transplantation, run by West China Hospital at 1 site in China.
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 2 inclusion and 6 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 10 Jun 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 China. 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?
The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications. (time frame: through study completion, an average of 1 year). 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 NCT04261816, 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 10 Jun 2021.