Hypotension After Reperfusion in Liver Transplantation
Conditions
Keywords
postreperfusion syndrome, phenylephrine, epinephrine, liver transplantation
Brief summary
Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver transplantation which is characterized by an acute drop in blood pressure immediately after the prefusion is restored to the transplanted liver. We hypothesized that PRS would be prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion in liver transplantation.
Interventions
DRUGphenylephrine
100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion
DRUGepinephrine
10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion
DRUGplacebo control
10ml of normal saline is administered at the time of reperfusion
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- adults scheduled to undergo liver transplantation
Exclusion criteria
\- pediatric liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Postreperfusion Syndrome (PRS) | immediately after reperfusion | the number of patients who showed PRS (hypotension defined as \< 30% of baseline mean arterial pressure \[MAP\] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group |
Countries
South Korea
Participant flow
Recruitment details
Of the 128 eligible candidates, 96 patients were enrolled in this study from Mar 2010 to Oct 2010 at SNUH.
Pre-assignment details
Excluded(n=32) Children n=13 Coronary artery disease n=2 Valvular heart disease n=2 Atrial fibrillation n=1 Enrolled in other trial n=2 refusal to participate n=12 Randomized (n=96) intraop portal vein rupture n=1 data recording error n=1 procedure failure n=1 Analyzed n=93 (n=31 er each group)
Participants by arm
| Arm | Count |
|---|---|
| Phenylephrine 100 mcg of phenylephrine is administered at the time of reperfusion | 31 |
| Epinephrine 10 mcg of epinephrine is administered iv at the time of reperfusion | 33 |
| Control 10 ml of normal saline is administered at the time of reperfusion | 32 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Control | Total | Phenylephrine | Epinephrine |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 9 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 87 Participants | 27 Participants | 31 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 11 | 53 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 9 | 55 years STANDARD_DEVIATION 10 |
| Region of Enrollment Korea, Republic of | 32 participants | 96 participants | 31 participants | 33 participants |
| Sex: Female, Male Female | 7 Participants | 26 Participants | 10 Participants | 9 Participants |
| Sex: Female, Male Male | 25 Participants | 70 Participants | 21 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 33 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 | 0 / 32 |
Outcome results
Primary
Occurrence of Postreperfusion Syndrome (PRS)
the number of patients who showed PRS (hypotension defined as \< 30% of baseline mean arterial pressure \[MAP\] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group
Time frame: immediately after reperfusion
Population: Initial assessment for eligibility: n=128 32 patients who did not meet the criteria were excluded 96 patients were randomized Contorol (32 patients) --\> 1 patient was excluded because of portalvein rupture Epinephrine (33 patients) --\> data recording error (1 patient) practice error (1 patient) Phenylephrine group (31 patient)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenylephrine | Occurrence of Postreperfusion Syndrome (PRS) | 45 percentage of participants |
| Epinephrine | Occurrence of Postreperfusion Syndrome (PRS) | 39 percentage of participants |
| Control | Occurrence of Postreperfusion Syndrome (PRS) | 87 percentage of participants |