Postoperative Graft Function
Conditions
Keywords
TEE, orthotopic liver transplant, EAD
Brief summary
Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total bilirubin.
Detailed description
During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and adjusted with donor graft weight. This index, HVF index, was assessed for correlation with EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess the predictive power for EAD, prolonged INR, platelet, and total bilirubin.
Interventions
OTHERNO internvention
NO internvention
Sponsors
Henry Ford Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique \-
Exclusion criteria
TEE absolute contraindication patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EAD | EAD met at any point within the first 7 days status post OLT | Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on postoperative day 7. and ALT/AST \> 2,000 IU/L Systolic and diastolic hepatic vein flow index was assessed intraoperatively in neohepatic phase in both of EAD and non EAD group, and reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Rejection | Acute rejection noted at any point within 6-8 weeks post transplant | Acute rejection noted with biopsy at any point within 6 to 8 weeks post-transplant |
| Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil) | postoperative day 7 assessment | Normal total bilirubin \< 1.2 mg/dL |
| Prolonged (>Seven Days) Time to Normalize INR (TIME Inr) | postoperative day 7 assessment | Normal INR \< 1.16 |
| Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt). | postoperative day 7 assessment | Normal platelet count \> 140 B/L |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EAD After Orthotopic Liver Transplantation Early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on day 7, and ALT/AST \> 2,000 IU/L within the first 7 days.
NO intervention | 26 |
| No EAD After Orthotopic Liver Transplantation No EAD noted after orthotopic liver transplantation
NO intervention | 71 |
| Total | 97 |
Baseline characteristics
| Characteristic | No EAD After Orthotopic Liver Transplantation | Total | EAD After Orthotopic Liver Transplantation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 46 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 51 Participants | 10 Participants |
| Age, Continuous | 55 years | 56 years | 58 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 71 participants | 97 participants | 26 participants |
| Sex: Female, Male Female | 28 Participants | 39 Participants | 11 Participants |
| Sex: Female, Male Male | 43 Participants | 58 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 76 |
| other Total, other adverse events | 0 / 26 | 0 / 71 |
| serious Total, serious adverse events | 0 / 26 | 0 / 71 |
Outcome results
Primary
EAD
Primary outcome was early allograft dysfunction (EAD), which was defined by the presence of one or more of the following: total bilirubin (t-bil) ≥ 10 mg/dL (171 μmol/L) or, INR ≥ 1.6 on postoperative day 7. and ALT/AST \> 2,000 IU/L Systolic and diastolic hepatic vein flow index was assessed intraoperatively in neohepatic phase in both of EAD and non EAD group, and reported.
Time frame: EAD met at any point within the first 7 days status post OLT
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EAD After Orthotopic Liver Transplantation | EAD | HV flow systolic index | 1.23 L/kg/min |
| EAD After Orthotopic Liver Transplantation | EAD | HV flow diastolic index | 0.87 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | EAD | HV flow systolic index | 2.19 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | EAD | HV flow diastolic index | 1.54 L/kg/min |
Secondary
Acute Rejection
Acute rejection noted with biopsy at any point within 6 to 8 weeks post-transplant
Time frame: Acute rejection noted at any point within 6-8 weeks post transplant
Population: Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EAD After Orthotopic Liver Transplantation | Acute Rejection | HV flow systolic index | 0.738 L/kg/min |
| EAD After Orthotopic Liver Transplantation | Acute Rejection | HV flow diastolic index | 0.571 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Acute Rejection | HV flow systolic index | 1.535 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Acute Rejection | HV flow diastolic index | 1.101 L/kg/min |
Secondary
Prolonged (>Seven Days) Time to Normalize INR (TIME Inr)
Normal INR \< 1.16
Time frame: postoperative day 7 assessment
Population: Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize INR (TIME Inr) | HV flow systolic index | 1.081 L/kg/min |
| EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize INR (TIME Inr) | HV flow diastolic index | 0.954 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize INR (TIME Inr) | HV flow systolic index | 1.484 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize INR (TIME Inr) | HV flow diastolic index | 1.050 L/kg/min |
Secondary
Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt).
Normal platelet count \> 140 B/L
Time frame: postoperative day 7 assessment
Population: Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt). | HV flow systolic index | 1.341 L/kg/min |
| EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt). | HV flow diastolic index | 0.829 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt). | HV flow systolic index | 1.379 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt). | HV flow diastolic index | 1.024 L/kg/min |
Secondary
Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil)
Normal total bilirubin \< 1.2 mg/dL
Time frame: postoperative day 7 assessment
Population: Adult patients undergoing the orthotopic liver transplant piggy-back technique with TEE-measured HV flow
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil) | HV flow systolic index | 1.086 L/kg/min |
| EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil) | HV flow diastolic index | 0.806 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil) | HV flow diastolic index | 1.351 L/kg/min |
| No EAD After Orthotopic Liver Transplantation | Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil) | HV flow systolic index | 2.051 L/kg/min |
Post Hoc
Inter-rater Reliability Analyses of HVFi
Intra-rater and inter-rater reliability analyses of HVFi are performed using intraclass correlation coefficient (ICC). We randomly pick up 30 images and obtain consistency ICC for inter-observer variability using all three investigators (A, B, and C). For inter-observer variability, 3 investigators post-hoc determine HVFi based on the pulse-wave Doppler signal.
Time frame: Timing is postoperative at any point. Duration is a day.
Population: Randomly chosen 30 patients among enrolled patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| EAD After Orthotopic Liver Transplantation | Inter-rater Reliability Analyses of HVFi | 0.997 ICC |
| No EAD After Orthotopic Liver Transplantation | Inter-rater Reliability Analyses of HVFi | 0.993 ICC |
Post Hoc
Intra-rater Reliability Analyses of HVFi
Intra-rater and inter-rater reliability analyses of HVFi are performed using intraclass correlation coefficient (ICC). We randomly pick up 30 images and obtain consistency ICC for inter-observer variability using all three investigators (A, B, and C), and absolute-agreement ICC for intra-observer variability using investigator C, who measure all images twice with an interval between 6 and 8 weeks. For inter-observer variability, 3 investigators post-hoc determine HVFi based on the pulse-wave Doppler signal.
Time frame: Timing is postoperatively at any point 6-8 weeks. Duration is a day.
Population: Randomly chosen 30 patients among enrolled patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EAD After Orthotopic Liver Transplantation | Intra-rater Reliability Analyses of HVFi | 0.998 ICC |
| No EAD After Orthotopic Liver Transplantation | Intra-rater Reliability Analyses of HVFi | 0.998 ICC |