Hypotension After Reperfusion in Liver TransplantationNCT01080625

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

A study testing phenylephrine and epinephrine in people with Hypotension After Reperfusion in Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypotension After Reperfusion in Liver Transplantation
What is being tested?: phenylephrine and epinephrine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteSouth Korea
Study dates: Apr 2010to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adults scheduled to undergo liver transplantation

Who cannot join

pediatric liver transplantation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: Effect of Preventive Medicine on the Postreperfusion Syndrome

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.

Conditions: Hypotension After Reperfusion in Liver Transplantation
Being tested: phenylephrine, epinephrine, placebo control
Keywords: postreperfusion syndrome, phenylephrine, epinephrine, liver transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

phenylephrineDrug
100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion
epinephrineDrug
10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion
placebo controlDrug
10ml of normal saline is administered at the time of reperfusion

Study groups in NCT01080625
Study group	Role	What they receive
phenylephrine	Experimental	100 mcg of phenylephrine is administered at the time of reperfusion Receives: Drug: phenylephrine
epinephrine	Experimental	10 mcg of epinephrine is administered iv at the time of reperfusion Receives: Drug: epinephrine
control	Placebo comparator	10 ml of normal saline is administered at the time of reperfusion Receives: Drug: placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: immediately after reperfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Oct 2011

First posted4 Mar 2010 (estimated)
Study startApr 2010
Primary completionSep 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypotension After Reperfusion in Liver TransplantationStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01080625
Sponsor's protocol ID: CWJung_phen_epi_liver TPL
Status last verified: May 2012
First submitted: 2 Mar 2010
Last updated: 3 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22821620

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Preventive Medicine on the Postreperfusion Syndrome
ClinicalTrials.gov ID: NCT01080625
Acronym / sponsor ID: CWJung_phen_epi_liver TPL
Conditions: Hypotension After Reperfusion in Liver Transplantation
Keywords: postreperfusion syndrome, phenylephrine, epinephrine, liver transplantation
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Apr 2010
Primary completion: Sep 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 4 Mar 2010 (estimated)
Results: Posted 12 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
phenylephrine	Experimental	Drug: phenylephrine100 mcg of phenylephrine is administered at the time of reperfusion
epinephrine	Experimental	Drug: epinephrine10 mcg of epinephrine is administered iv at the time of reperfusion
control	Placebo comparator	Drug: placebo control10 ml of normal saline is administered at the time of reperfusion

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

adults scheduled to undergo liver transplantation

Key exclusion criteria (1 listed)

pediatric liver transplantation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
phenylephrine100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion	Drug	phenylephrine
epinephrine10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion	Drug	epinephrine
placebo control10ml of normal saline is administered at the time of reperfusion	Drug	control

Primary outcome

Occurrence of Postreperfusion Syndrome (PRS)
Time frame: 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

Results and safety

Results posted to the registry on 12 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phenylephrine	31	31
Epinephrine	33	31
Control	32	31

Primary outcome: Occurrence of Postreperfusion Syndrome (PRS)

Time frame: immediately after reperfusion. Number. Unit: percentage of participants

Measure	Phenylephrine n = 31	Epinephrine n = 31	Control n = 31
Value	45	39	87

Population analysed: 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)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phenylephrine	0 of 31 (0%)	0 of 31 (0%)	Not reported
Epinephrine	0 of 33 (0%)	0 of 33 (0%)	Not reported
Control	0 of 32 (0%)	0 of 32 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22821620Ryu 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chul-Woo Jung, MD principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing phenylephrine and epinephrine in people with Hypotension After Reperfusion in Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Postreperfusion Syndrome (PRS) (time frame: immediately after reperfusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01080625, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.