Impact of Age and BMI on Liver Transplant Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplant; Complications; Perioperative/Postoperative Complications
• Intervention / Treatment: Procedure: Living Donor; Procedure: Cadaveric

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 Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15207
      • UPMC Montefiore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with end-stage liver disease, cirrhosis, or cancer requiring a liver transplant.

Description

Inclusion Criteria:

• All patients who received a liver transplant at UPMC- Montefiore Hospital Age> 18

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Living Donor Liver Transplant Recipient; Patients who have received a living donor liver transplant.	Procedure: Living Donor; Living Donor Organ Transplant
Deceased Donor Liver Transplant Recipient; Patients who have received either a Deceased by Circulatory Death or Deceased by Brain Death Liver Transplant	Procedure: Cadaveric; Cadaveric Organ Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Function 30 day	How well does the organ function	30 day
Mortality	Mortality at 1 year	1 year
Graft Survival 1 year	Survival of Organ at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Complications	Any complications in the perioperative period	30 day
Length of Stay- Total and ICU	How long after surgery before patient is discharged from ICU and from Hospital	Up to 6 months
Duration of Intubation/Ventilation	Time from Surgery End to Extubation or no longer requiring ventilatory support	Up to 6 months
Postoperative Complications	Complications in the postoperative period- Renal, Infectious Disease, Pulmonary, Cardiac, Transplant related, Reintubation, Reoperation	Up to 6 months
Blood Transfusion	Amount of blood transfusion required intraoperatively	Up to 2 days
Vasoactive Medication	Amount and Type of Vasoactive Medication used at procedure end	Up to 2 days

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Liver Transplantation; Age Related Outcomes; BMI related outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: STUDY20070432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plans

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No