Liver Transplant DisorderEarly Phase 1NCT05277623
Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant
A Early Phase 1 study testing Mannitol and 0.9% normal saline in people with Liver Transplant Disorder, run by Ain Shams University at 1 site in Egypt.
Trial summary
Postreperfusion syndrome during living liver transplants remains a serious concern for transplant anesthesiologists. This syndrome is responsible for decreases in systemic blood pressure, systemic vascular resistance, and cardiac output and can even lead to cardiac arrest. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Liver Transplant Disorder
- What is being tested?
- Mannitol and 0.9% normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2022to 10 Dec 2022
- Phase
- Early Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with end-stage liver disease who will undergo living donor transplantation.
Who cannot join
- Patients with a history of portopulmonary hypertension.
- Hepatopulmonary syndrome.
- Cirrhotic cardiomyopathy.
- Hepatorenal syndrome types 1 and 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant: a Randomized Clinical Trial
Postreperfusion syndrome during living liver transplants remains a serious concern for transplant anesthesiologists. This syndrome is responsible for decreases in systemic blood pressure, systemic vascular resistance, and cardiac output and can even lead to cardiac arrest. Delayed graft function and primary graft nonfunction are closely related to postreperfusion syndrome (Therefore, attenuating the syndrome during anesthesia is of great importance.
- Conditions
- Liver Transplant Disorder
- Being tested
- Mannitol, 0.9% normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
During the anhepatic phase, the patients in the mannitol group (30) will receive 1 g/kg
0.9% normal salineOther
the same amount of 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| mannitol group | Active comparator | Not described Receives: Drug: Mannitol |
| control group | Placebo comparator | Not described Receives: Other: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial blood pressure
postreperfusion mean blood pressure
Measured: one hour after reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start4 Apr 2022
- Primary completion5 Nov 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant DisorderStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277623
- Sponsor's protocol ID
- R 42/ 2022
- Status last verified
- Jan 2023
- First submitted
- 4 Mar 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mannitol on Postreperfusion Syndrome During Living Donor Liver Transplant: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05277623
- Acronym / sponsor ID
- R 42/ 2022
- Conditions
- Liver Transplant Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 14 Mar 2022 (actual)
- 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.
Postreperfusion syndrome during living liver transplants remains a serious concern for transplant anesthesiologists. This syndrome is responsible for decreases in systemic blood pressure, systemic vascular resistance, and cardiac output and can even lead to cardiac arrest. Delayed graft function and primary graft nonfunction are closely related to postreperfusion syndrome (Therefore, attenuating the syndrome during anesthesia is of great importance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mannitol group | Active comparator | Drug: Mannitol |
| control group | Placebo comparator | Other: 0.9% normal saline |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with end-stage liver disease who will undergo living donor transplantation.
Key exclusion criteria (4 listed)
- Patients with a history of portopulmonary hypertension.
- Hepatopulmonary syndrome.
- Cirrhotic cardiomyopathy.
- Hepatorenal syndrome types 1 and 2.
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 |
|---|---|---|
| MannitolDuring the anhepatic phase, the patients in the mannitol group (30) will receive 1 g/kg | Drug | mannitol group |
| 0.9% normal salinethe same amount of 0.9% normal saline | Other | control group |
Primary outcome
mean arterial blood pressure
Time frame: one hour after reperfusion
postreperfusion mean blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mannitol and 0.9% normal saline in people with Liver Transplant Disorder, run by Ain Shams University at 1 site 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 4 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 18 Jan 2023. 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 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mean arterial blood pressure (time frame: one hour after reperfusion). 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 18 Jan 2023.