Liver Transplant; ComplicationsNCT04853641
Impact of Age and BMI on Liver Transplant Outcomes
An observational study of Liver Transplant; Complications and Perioperative/Postoperative Complications, run by University of Pittsburgh at 1 site in United States.
Trial summary
Prospectively enrolled retrospective chart review and Liver Transplant database review to determine the modifiable and nonmodifiable risk factors specifically relating to Living Donor Liver Transplants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Perioperative/Postoperative Complications
- What is being tested?
- Cadaveric and Living Donor
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 30 Nov 2022
- 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 with end-stage liver disease, cirrhosis, or cancer requiring a liver transplant.
Who may be able to join
- All patients who received a liver transplant at UPMC- Montefiore Hospital Age> 18
Who cannot join
- Excludes Children (<18 years old) as they do not receive their operation under the same protocols Lost to follow-up prior to 1 year Participation in alternate research protocol that significantly altered the care they received in the perioperative period that may make their inclusion skew results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Advanced Age and High BMI on Short-term Outcomes in Live-donor Liver Transplant Recipients
Prospectively enrolled retrospective chart review and Liver Transplant database review to determine the modifiable and nonmodifiable risk factors specifically relating to Living Donor Liver Transplants. To observe the impact of age and BMI on graft outcomes and whether they impact the intraoperative management, post-operative length of stay, and complications.
Read the detailed description
There has been a great deal of research into the characteristics of the donor for organ transplant, with older donors and those with more comorbidities having worse function once the organ is implanted. There has not been a great deal of research in the United States about the recipient's characteristic including age and BMI and the effects on donor organ function. With increasingly expanded criteria for organ recipients especially in the field of living donor organs the investigators plan to show the impact of older age and increased BMI on newly transplanted organs.
- Being tested
- Cadaveric, Living Donor
- Keywords
- Age Related Outcomes, BMI related outcomes, Liver Transplantation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadavericProcedure or surgery
Cadaveric Organ Transplant
Living DonorProcedure or surgery
Living Donor Organ Transplant
| Study group | Role | What they receive |
|---|---|---|
| Living Donor Liver Transplant Recipient | Patients who have received a living donor liver transplant. Receives: Procedure: Living Donor | |
| Deceased Donor Liver Transplant Recipient | Patients who have received either a Deceased by Circulatory Death or Deceased by Brain Death Liver Transplant Receives: Procedure: Cadaveric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Function 30 day
How well does the organ function
Measured: 30 day
Mortality
Mortality at 1 year
Measured: 1 year
Graft Survival 1 year
Survival of Organ at 1 year
Measured: 1 year
Secondary outcomes (6)
Perioperative Complications
Any complications in the perioperative period
Measured: 30 day
Length of Stay- Total and ICU
How long after surgery before patient is discharged from ICU and from Hospital
Measured: Up to 6 months
Duration of Intubation/Ventilation
Time from Surgery End to Extubation or no longer requiring ventilatory support
Measured: Up to 6 months
Postoperative Complications
Complications in the postoperative period- Renal, Infectious Disease, Pulmonary, Cardiac, Transplant related, Reintubation, Reoperation
Measured: Up to 6 months
Blood Transfusion
Amount of blood transfusion required intraoperatively
Measured: Up to 2 days
Vasoactive Medication
Amount and Type of Vasoactive Medication used at procedure end
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibtesam Hilmi, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853641
- Sponsor's protocol ID
- STUDY20070432
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plans
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Advanced Age and High BMI on Short-term Outcomes in Live-donor Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT04853641
- Acronym / sponsor ID
- STUDY20070432
- Keywords
- Age Related Outcomes, BMI related outcomes, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 21 Apr 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.
Prospectively enrolled retrospective chart review and Liver Transplant database review to determine the modifiable and nonmodifiable risk factors specifically relating to Living Donor Liver Transplants. To observe the impact of age and BMI on graft outcomes and whether they impact the intraoperative management, post-operative length of stay, and complications.
Detailed description
There has been a great deal of research into the characteristics of the donor for organ transplant, with older donors and those with more comorbidities having worse function once the organ is implanted. There has not been a great deal of research in the United States about the recipient's characteristic including age and BMI and the effects on donor organ function. With increasingly expanded criteria for organ recipients especially in the field of living donor organs the investigators plan to show the impact of older age and increased BMI on newly transplanted organs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Living Donor Liver Transplant Recipient | – | Procedure: Living DonorPatients who have received a living donor liver transplant. |
| Deceased Donor Liver Transplant Recipient | – | Procedure: CadavericPatients who have received either a Deceased by Circulatory Death or Deceased by Brain Death Liver Transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage liver disease, cirrhosis, or cancer requiring a liver transplant.
Key inclusion criteria (1 listed)
- All patients who received a liver transplant at UPMC- Montefiore Hospital Age> 18
Key exclusion criteria (1 listed)
- Excludes Children (<18 years old) as they do not receive their operation under the same protocols Lost to follow-up prior to 1 year Participation in alternate research protocol that significantly altered the care they received in the perioperative period that may make their inclusion skew results.
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 |
|---|---|---|
| CadavericCadaveric Organ Transplant | Procedure or surgery | Deceased Donor Liver Transplant Recipient |
| Living DonorLiving Donor Organ Transplant | Procedure or surgery | Living Donor Liver Transplant Recipient |
Primary outcome
Graft Function 30 day
Time frame: 30 day
How well does the organ function
Mortality
Time frame: 1 year
Mortality at 1 year
Graft Survival 1 year
Time frame: 1 year
Survival of Organ at 1 year
6 secondary outcomes
Perioperative Complications
Time frame: 30 day
Length of Stay- Total and ICU
Time frame: Up to 6 months
Duration of Intubation/Ventilation
Time frame: Up to 6 months
Postoperative Complications
Time frame: Up to 6 months
Blood Transfusion
Time frame: Up to 2 days
Vasoactive Medication
Time frame: Up to 2 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 28 Apr 2023.
- Individual participant dataSharing planned: No. No current plans
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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 Transplant; Complications and Perioperative/Postoperative Complications, run by University of Pittsburgh at 1 site in United States.
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 28 Apr 2023. 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 United States. 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?
Graft Function 30 day (time frame: 30 day). The study lists 3 primary outcomes in all. 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 28 Apr 2023.