Does metabolomic incompatibility between living liver donors and recipients predict early allograft dysfunction in liver transplantation?

In recipients of liver transplantation, does metabolomic incompatibility to donors lead to early allograft dysfunction?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000446561

Enrollment

154

Registered

2015-05-08

Start date

2015-05-21

Completion date

2018-04-17

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The liver is an essential organ in human body because it possesses synthetic, metabolic, secretory and excretory functions. For patients with acute and chronic end-stage liver disease, liver transplantation has been established as a viable treatment, and its success partly depends on proper organ retrieval, adequate donor assessment and optimal peri-operative conditions. The aim of the study is to determine the association of metabolomic incompatibility between donor and recipient andto predict early allograft dysfunction in liver transplantation.

Interventions

Blood and urine samples will be collected peri-operatively. Samples of liver donors will be collected before and after general anesthesia is conducted in the operating room. Samples of the recipients will be collected at several time points: (T1) before induction as baseline, (T2) after induction during general anesthesia, (T3) before the end of anhepatic phase, (T4) 2 hours post reperfusion, (T5) day 1 post-operatively and (T6) day 5 post-operatively. Hemodynamic data will also be collected at these time points. At day 7, liver transplant clinical outcomes will be assessed and classified as early allograft dysfunction (EAD) for grafts meeting one criterion or more (bilirubin greater than or equal to 10mg/dl, INR greater than or equal to 1.6, alanine (ALT) or aspartate (AST) amniotransferase greater than 2000IU/L within the first 7 days; as immediate graft function (IGF) for grafts with values below the cut-off points mentioned above; and as primary non function (PNF) for patients with irreversible graft dysfunction without detectable technical or immunological problems.

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion criteria for donor: 1. No history of liver disease 2. No medical history of cancer in the last 10 years 3. No HBsAg, no hepatitis C virus or HIV antibodies Inclusion criteria for recipient: 1. Patients with liver cirrhosis or hepatocellular carcinoma in need for liver transplantation

Exclusion criteria

Exclusion criteria for donor: 1. Refusal to sign informed consent 2. Age <20 years old Exclusion criterial for recipient: 1. Refusal to sign informed consent 2. Recent sepsis or shock status 3. History of hepatoencephalopathy 4. History of hepatorenal syndrome 5. Anticipated pulmonary hypertension with preoperative pulmonary wedge pressure >35mmHg

Outcome results