Ischemia Reperfusion Injury
Conditions
Keywords
Liver transplantation, Graft rinse, Ischemia reperfusion injury
Brief summary
The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients.
Detailed description
All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.
Interventions
PROCEDUREPurge
In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program
Exclusion criteria
* re-transplantation * Previous upper abdominal operation * Budd Chiari syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure | 5 minutes post-reperfusion | The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biliary Complications (Participants) | 3 months | Participants who developed biliary complications in three months period (Participant) |
| Ischemia Reperfusion Injury | 7 days | incidence of ischemia reperfusion injury in the transplanted graft |
| Post-operative Infectious Complications | 30 days | — |
| 3 Months Mortality | 3 Months | mortality within first 3 post-operative months |
Countries
Egypt
Participant flow
Recruitment details
Candidates recruited from patients admitted for living donor liver transplantation in Mansoura liver transplantation unit
Participants by arm
| Arm | Count |
|---|---|
| Purge The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping | 40 |
| No Purge The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Purge | No Purge | Total |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 6.19 | 50.9 years STANDARD_DEVIATION 7.62 | 51.15 years STANDARD_DEVIATION 6.94 |
| Region of Enrollment Egypt | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 32 Participants | 34 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 40 | 15 / 40 |
| serious Total, serious adverse events | 4 / 40 | 3 / 40 |
Outcome results
Primary
Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure
The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping
Time frame: 5 minutes post-reperfusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Purge | Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure | 66.03 mmHg | Standard Deviation 6.13 |
| No Purge | Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure | 57.75 mmHg | Standard Deviation 5.91 |
Secondary
3 Months Mortality
mortality within first 3 post-operative months
Time frame: 3 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Purge | 3 Months Mortality | 4 participants |
| No Purge | 3 Months Mortality | 3 participants |
Secondary
Biliary Complications (Participants)
Participants who developed biliary complications in three months period (Participant)
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Purge | Biliary Complications (Participants) | 10 participants |
| No Purge | Biliary Complications (Participants) | 6 participants |
Secondary
Ischemia Reperfusion Injury
incidence of ischemia reperfusion injury in the transplanted graft
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Purge | Ischemia Reperfusion Injury | 3 participants |
| No Purge | Ischemia Reperfusion Injury | 2 participants |
Secondary
Post-operative Infectious Complications
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Purge | Post-operative Infectious Complications | 9 participants |
| No Purge | Post-operative Infectious Complications | 8 participants |