Impact of Age and BMI on Liver Transplant Outcomes

Completed

• Conditions: Liver Transplant; Complications; Perioperative/Postoperative Complications
• Interventions: Procedure: Living Donor; Procedure: Cadaveric

• Registration Number: NCT04853641
• Lead Sponsor: University of Pittsburgh

Brief 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. 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 Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Primary Completion: 2022-06-30
• Study Completion: 2022-11-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Living Donor Liver Transplant Recipient	Living Donor	Patients who have received a living donor liver transplant.
Deceased Donor Liver Transplant Recipient	Cadaveric	Patients who have received either a Deceased by Circulatory Death or Deceased by Brain Death Liver Transplant

Primary Outcome Measures

Name	Time	Method
Graft Function 30 day	30 day	How well does the organ function
Mortality	1 year	Mortality at 1 year
Graft Survival 1 year	1 year	Survival of Organ at 1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UPMC Montefiore; 🇺🇸 Pittsburgh, Pennsylvania, United States