HypotensionIPLDLTNCT02845154
Intermittent Portal and Graft Purge in Living Donor Liver Transplantation
A study testing bolus purge and Intermittent purge in people with Hypotension and Ischemia Reperfusion Injury, run by Mansoura University at 3 sites in Egypt.
Trial summary
Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hypotension, Ischemia Reperfusion Injury
- What is being tested?
- bolus purge and Intermittent purge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesEgypt
- Study dates
- Oct 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- living donor liver transplantation recipients
Who cannot join
- Non
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites, 3 recruiting
- Recruiting
Liver transplantation program - Gastroenterology surgical center
Al Mansurah, Dakahlia Governorate, 35511
Amr M Yassen, MD, +201001497044, amryassen@hotmail.com
Waleed R alsarraf, MD, +201222322727, welsarraf@yahoo.com
- Recruiting
Liver transplantation project - Gastroenterology surgical center - Mansoura university
Al Mansurah, Dakahlia Governorate, 35511
Amr M Yassen, MD, +201001497044, amryassen@hotmail.com
Waleed R Elsarraf, MD, +201222322727, welsarraf@gmail.com
- Recruiting
Gastroenterology surgical center - Mansoura university
Al Mansurah, Dakahlia Governorate, 35516
Amr M Yassen, MD, +201001497044, amryassen@hotmail.com
About this study
Official title: Intermittent Anti-grade Portal and Graft Purge Ameliorates Post-reperfusion Syndrome in Living Donor Liver Transplantation Recipients. A Prospective, Randomised Controlled Trial
Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. The investigators will investigate the effect of acute conditioning of the recipients circulation to the vasoactive mediators in the graft as well as the congested intestine through intermittent purging of graft contents into the patient's systemic circulation in living donor liver transplantation.
Read the detailed description
Patients are subjected to living donor liver transplantation. In this type of grafts, cold ischemia time is minimal and the graft contents of preservative solution are less than cadaveric grafts. The investigators in the current research use HTC as a preservative solution. These factors justified the possibility of purging the graft and portal blood contents into the patient systemic circulation. The exposure to these fluids in this trial will be in an intermittent manner: the portal vein will be declamped for 5 seconds followed by 30 seconds of portal clamping. This will be repeated twice. The primary outcome objective in this trial will be the incidence of post-reperfusion syndrome. Secondary objectives include the severity of PRS, the incidence and severity of ischemia-reperfusion injury, graft and patient's survival.
- Conditions
- Hypotension, Ischemia Reperfusion Injury
- Being tested
- bolus purge, Intermittent purge
- Keywords
- Ischemia reperfusion, post-reperfusion syndrome, living donor liver transplantation, patient outcome
- Medical subject headings
- Hypotension, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bolus purgeOther
complete and uninterrupted purge
Intermittent purgeOther
intermittent portal purge
| Study group | Role | What they receive |
|---|---|---|
| Control (bolus purge) | Active comparator | The portal vein clamp will be totally released after end of portal vein anastomosis and all graft and portal blood contents are allowed free and complete access to the systemic circulation via the inferior vena cave Receives: Other: bolus purge |
| Intermittent Purge | Experimental | The portal clamp will be released in situ for 5 seconds to allow purge of the graft and portal contents into the systemic circulation, followed by 30 seconds of portal clamping again. This will be followed by another two cycles of 5 seconds declamping and 30 seconds clamping , then, the portal clamp will be completely released. Receives: Other: Intermittent purge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-reperfusion syndrome
Reduced Mean arterial blood pressure to the predefined value
Measured: 5 minutes after portal declamping
Secondary outcomes (3)
Graft ischemia reperfusion injury
Pathological assessment of IR injury based on Suzuli score
Measured: one week post-operative
Severity of post-reperfusion syndrome
% decrease in Mean arterial blood pressure
Measured: 5 minutes after portal declamping
One month patient mortality
Mortality within one post-operative month
Measured: one month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Yassen, Mansoura University
- Investigators
- Amr M Yassen, MD, Study director, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845154
- Sponsor's protocol ID
- LDLDPURGE
- Acronym
- IPLDLT
- Status last verified
- Dec 2016
- First submitted
- 16 Oct 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Anti-grade Portal and Graft Purge Ameliorates Post-reperfusion Syndrome in Living Donor Liver Transplantation Recipients. A Prospective, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02845154
- Acronym / sponsor ID
- IPLDLT / LDLDPURGE
- Conditions
- Hypotension, Ischemia Reperfusion Injury
- Keywords
- Ischemia reperfusion, post-reperfusion syndrome, living donor liver transplantation, patient outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. The investigators will investigate the effect of acute conditioning of the recipients circulation to the vasoactive mediators in the graft as well as the congested intestine through intermittent purging of graft contents into the patient's systemic circulation in living donor liver transplantation.
Detailed description
Patients are subjected to living donor liver transplantation. In this type of grafts, cold ischemia time is minimal and the graft contents of preservative solution are less than cadaveric grafts. The investigators in the current research use HTC as a preservative solution. These factors justified the possibility of purging the graft and portal blood contents into the patient systemic circulation. The exposure to these fluids in this trial will be in an intermittent manner: the portal vein will be declamped for 5 seconds followed by 30 seconds of portal clamping. This will be repeated twice. The primary outcome objective in this trial will be the incidence of post-reperfusion syndrome. Secondary objectives include the severity of PRS, the incidence and severity of ischemia-reperfusion injury, graft and patient's survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (bolus purge) | Active comparator | Other: bolus purgeThe portal vein clamp will be totally released after end of portal vein anastomosis and all graft and portal blood contents are allowed free and complete access to the systemic circulation via the inferior vena cave |
| Intermittent Purge | Experimental | Other: Intermittent purgeThe portal clamp will be released in situ for 5 seconds to allow purge of the graft and portal contents into the systemic circulation, followed by 30 seconds of portal clamping again. This will be followed by another two cycles of 5 seconds declamping and 30 seconds clamping , then, the portal clamp will be completely released. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- living donor liver transplantation recipients
Key exclusion criteria (1 listed)
- Non
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 |
|---|---|---|
| bolus purgecomplete and uninterrupted purge | Other | Control (bolus purge) |
| Intermittent purgeintermittent portal purge | Other | Intermittent Purge |
Primary outcome
Post-reperfusion syndrome
Time frame: 5 minutes after portal declamping
Reduced Mean arterial blood pressure to the predefined value
3 secondary outcomes
Graft ischemia reperfusion injury
Time frame: one week post-operative
Severity of post-reperfusion syndrome
Time frame: 5 minutes after portal declamping
One month patient mortality
Time frame: one month post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Amr M Yassen, MD study director
Mansoura Faculty of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bolus purge and Intermittent purge in people with Hypotension and Ischemia Reperfusion Injury, run by Mansoura University at 3 sites in Egypt.
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: status not confirmed, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Yassen, MD (+201001497044, amryassen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-reperfusion syndrome (time frame: 5 minutes after portal declamping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2017.