Impact of Age and BMI on Liver Transplant Outcomes

Perioperative/Postoperative Complications Clinical Trial

Official title:

The Impact of Advanced Age and High BMI on Short-term Outcomes in Live-donor Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853641
• Other study ID #: STUDY20070432
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: November 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• Cadaveric
Cadaveric Organ Transplant
• Living Donor
Living Donor Organ Transplant

Locations

Country	Name	City	State
United States	UPMC Montefiore	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft Function 30 day	How well does the organ function	30 day
Primary	Mortality	Mortality at 1 year	1 year
Primary	Graft Survival 1 year	Survival of Organ at 1 year	1 year
Secondary	Perioperative Complications	Any complications in the perioperative period	30 day
Secondary	Length of Stay- Total and ICU	How long after surgery before patient is discharged from ICU and from Hospital	Up to 6 months
Secondary	Duration of Intubation/Ventilation	Time from Surgery End to Extubation or no longer requiring ventilatory support	Up to 6 months
Secondary	Postoperative Complications	Complications in the postoperative period- Renal, Infectious Disease, Pulmonary, Cardiac, Transplant related, Reintubation, Reoperation	Up to 6 months
Secondary	Blood Transfusion	Amount of blood transfusion required intraoperatively	Up to 2 days
Secondary	Vasoactive Medication	Amount and Type of Vasoactive Medication used at procedure end	Up to 2 days