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Completed

NCT Number: NCT04853641

Impact of Age and BMI on Liver Transplant Outcomes

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.

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Key information

Conditions

Liver Transplant; Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC Montefiore

Pittsburgh, Pennsylvania, 15207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cadaveric

Procedure

Cadaveric Organ Transplant

Living Donor

Procedure

Living Donor Organ Transplant

Primary outcomes

  1. Graft Function 30 day

    Time frame: 30 day

    How well does the organ function

  2. Mortality

    Time frame: 1 year

    Mortality at 1 year

  3. Graft Survival 1 year

    Time frame: 1 year

    Survival of Organ at 1 year

Secondary outcomes

  1. Perioperative Complications

    Time frame: 30 day

    Any complications in the perioperative period

  2. Length of Stay- Total and ICU

    Time frame: Up to 6 months

    How long after surgery before patient is discharged from ICU and from Hospital

  3. Duration of Intubation/Ventilation

    Time frame: Up to 6 months

    Time from Surgery End to Extubation or no longer requiring ventilatory support

  4. Postoperative Complications

    Time frame: Up to 6 months

    Complications in the postoperative period- Renal, Infectious Disease, Pulmonary, Cardiac, Transplant related, Reintubation, Reoperation

  5. Blood Transfusion

    Time frame: Up to 2 days

    Amount of blood transfusion required intraoperatively

  6. Vasoactive Medication

    Time frame: Up to 2 days

    Amount and Type of Vasoactive Medication used at procedure end

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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