Trial Outcomes & Findings for Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation (NCT NCT01080625)

NCT ID: NCT01080625

Last Updated: 2012-05-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: immediately after reperfusion
• Results posted on: 2012-05-03

Participant Flow

Of the 128 eligible candidates, 96 patients were enrolled in this study from Mar 2010 to Oct 2010 at SNUH.

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)

Participant milestones

Measure	Phenylephrine 100 mcg of phenylephrine is administered at the time of reperfusion	Epinephrine 10 mcg of epinephrine is administered iv at the time of reperfusion	Control 10 ml of normal saline is administered at the time of reperfusion
Overall Study STARTED	31	33	32
Overall Study COMPLETED	31	31	31
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Measure	Phenylephrine 100 mcg of phenylephrine is administered at the time of reperfusion	Epinephrine 10 mcg of epinephrine is administered iv at the time of reperfusion	Control 10 ml of normal saline is administered at the time of reperfusion
Overall Study Physician Decision	0	2	1

Baseline Characteristics

Effect of Epinephrine/ Phenylephrine for Preventing the Postreperfusion Syndrome During Reperfusion in Liver Transplantation

Baseline characteristics by cohort

Measure	Phenylephrine n=31 Participants 100 mcg of phenylephrine is administered at the time of reperfusion	Epinephrine n=33 Participants 10 mcg of epinephrine is administered iv at the time of reperfusion	Control n=32 Participants 10 ml of normal saline is administered at the time of reperfusion	Total n=96 Participants Total of all reporting groups
Region of Enrollment Korea, Republic of	31 participants n=5 Participants	33 participants n=7 Participants	32 participants n=5 Participants	96 participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	31 Participants n=7 Participants	29 Participants n=5 Participants	87 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Age Continuous	52 years STANDARD_DEVIATION 9 • n=5 Participants	55 years STANDARD_DEVIATION 10 • n=7 Participants	52 years STANDARD_DEVIATION 11 • n=5 Participants	53 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	26 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	70 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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)

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

Outcome measures

Measure	Phenylephrine n=31 Participants 100 mcg of phenylephrine is administered at the time of reperfusion	Epinephrine n=31 Participants 10 mcg of epinephrine is administered iv at the time of reperfusion	Control n=31 Participants 10 ml of normal saline is administered at the time of reperfusion
Occurrence of Postreperfusion Syndrome (PRS)	45 percentage of participants	39 percentage of participants	87 percentage of participants

Adverse Events

Phenylephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chul-Woo Jung/ Assistant professor

SNUH

Phone: 82-2-2072-0640

Email: spss@snuh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place