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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phenylephrine | Experimental | 100 mcg of phenylephrine is administered at the time of reperfusion |
|
| epinephrine | Experimental | 10 mcg of epinephrine is administered iv at the time of reperfusion |
|
| control | Placebo Comparator | 10 ml of normal saline is administered at the time of reperfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenylephrine | Drug | 100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | immediately after reperfusion |
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Inclusion Criteria:
- adults scheduled to undergo liver transplantation
Exclusion Criteria:
- pediatric liver transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Chul-Woo Jung, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22821620 | Derived | Ryu HG, Jung CW, Lee HC, Cho YJ. Epinephrine and phenylephrine pretreatments for preventing postreperfusion syndrome during adult liver transplantation. Liver Transpl. 2012 Dec;18(12):1430-9. doi: 10.1002/lt.23511. |
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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)
Of the 128 eligible candidates, 96 patients were enrolled in this study from Mar 2010 to Oct 2010 at SNUH.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenylephrine | 100 mcg of phenylephrine is administered at the time of reperfusion |
| FG001 | Epinephrine | 10 mcg of epinephrine is administered iv at the time of reperfusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| epinephrine |
| Drug |
10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion |
|
| placebo control | Drug | 10ml of normal saline is administered at the time of reperfusion |
|
| FG002 | Control | 10 ml of normal saline is administered at the time of reperfusion |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenylephrine | 100 mcg of phenylephrine is administered at the time of reperfusion |
| BG001 | Epinephrine | 10 mcg of epinephrine is administered iv at the time of reperfusion |
| BG002 | Control | 10 ml of normal saline is administered at the time of reperfusion |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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) | Posted | Number | percentage of participants | immediately after reperfusion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phenylephrine | 100 mcg of phenylephrine is administered at the time of reperfusion | 0 | 31 | 0 | 31 | ||
| EG001 | Epinephrine | 10 mcg of epinephrine is administered iv at the time of reperfusion | 0 | 33 | 0 | 33 | ||
| EG002 | Control | 10 ml of normal saline is administered at the time of reperfusion | 0 | 32 | 0 | 32 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chul-Woo Jung/ Assistant professor | SNUH | 82-2-2072-0640 | spss@snuh.org |
| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|