Liver TransplantationNCT00842803
Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant
A study testing Albumin infusion (25% albumin) in people with Liver Transplantation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Albumin infusion (25% albumin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Canadian Transplant status 1 or 2
- Patients at the Royal Victoria Hospital, Montreal, Canada
Who cannot join
- Emergency liver transplant (canadian transplant status 3 or 4)
- patients who have received more than 300cc of albumin within 48 hours prior to transplant
- patients who underwent previous solid organ transplant
- multi-organs transplant recipients
- patients who had previous adverse reaction to human albumin solution
- patients who have religious restriction to receiving human blood products.
- patients or surrogate unable to give consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.
The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.
- Conditions
- Liver Transplantation
- Being tested
- Albumin infusion (25% albumin)
- Keywords
- Liver, transplant, albumin, outcome, Liver transplant recipients canadian transplant status 1 or 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin infusion (25% albumin)Drug
Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative |
| Albumin group | Experimental | Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative Receives: Drug: Albumin infusion (25% albumin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Transplant Liver Function Test (PTLFT)
Measured: Post-operative Day1 through 7 and Day 15,30, 45
Secondary outcomes (11)
Functional 6 minutes walking test
Measured: Post-operative
Calculated creatinine clearance
Measured: Post-operative day 1, 7, 15, 30, 45
Length of hospital stay
Measured: post-operative
ICU length of stay
Measured: post-operative
duration of mechanical ventilation
Measured: post-operative
duration of renal replacement therapy
Measured: postoperative
ICU readmission rate
Measured: post-operative
reintubation rate
Measured: post-operative
Post-operative infection rate
Measured: Post-operative
Need to re-operation unrelated to technical complication
Measured: post-operative
Functional hand grip Jamar Dynamometer hand grip test
Measured: Post-op day 7, 15, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842803
- Sponsor's protocol ID
- SDR-08-030
- Status last verified
- Sep 2009
- First submitted
- 11 Feb 2009
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00842803
- Acronym / sponsor ID
- SDR-08-030
- Conditions
- Liver Transplantation
- Keywords
- Liver, transplant, albumin, outcome, Liver transplant recipients canadian transplant status 1 or 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 12 Feb 2009 (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.
The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative |
| Albumin group | Experimental | Drug: Albumin infusion (25% albumin)Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Canadian Transplant status 1 or 2
- Patients at the Royal Victoria Hospital, Montreal, Canada
Key exclusion criteria (7 listed)
- Emergency liver transplant (canadian transplant status 3 or 4)
- patients who have received more than 300cc of albumin within 48 hours prior to transplant
- patients who underwent previous solid organ transplant
- multi-organs transplant recipients
- patients who had previous adverse reaction to human albumin solution
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 |
|---|---|---|
| Albumin infusion (25% albumin)Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative | Drug | Albumin group |
Primary outcome
Post Transplant Liver Function Test (PTLFT)
Time frame: Post-operative Day1 through 7 and Day 15,30, 45
11 secondary outcomes
Functional 6 minutes walking test
Time frame: Post-operative
Calculated creatinine clearance
Time frame: Post-operative day 1, 7, 15, 30, 45
Length of hospital stay
Time frame: post-operative
ICU length of stay
Time frame: post-operative
duration of mechanical ventilation
Time frame: post-operative
duration of renal replacement therapy
Time frame: postoperative
ICU readmission rate
Time frame: post-operative
reintubation rate
Time frame: post-operative
Post-operative infection rate
Time frame: Post-operative
Need to re-operation unrelated to technical complication
Time frame: post-operative
Functional hand grip Jamar Dynamometer hand grip test
Time frame: Post-op day 7, 15, 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin infusion (25% albumin) in people with Liver Transplantation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 7 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 18 Sep 2009. 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 Canada. 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 Mathieu Rousseau, MD (514.567.0292, mathieu.rousseau@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Transplant Liver Function Test (PTLFT) (time frame: Post-operative Day1 through 7 and Day 15,30, 45). 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 Sep 2009.