Other Complications of Liver TransplantPhase 4NCT01328132
Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant
A Phase 4 study testing Saline and 25% albumin in people with Other Complications of Liver Transplant, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to try to identify the dominant physiological mechanism so that we will be able to better identify patients that may benefit from the use of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Other Complications of Liver Transplant
- What is being tested?
- Saline and 25% albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Oct 2011
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Patients from the Critical care Unit
- Patients with a pulmonary artery occlusion catheter Inclusion:patients immediately following liver transplantation
Who cannot join
- Patients not giving informed consent
- Patients who have received > 300 ml of albumin within 24 hours prior to inclusion
- Patients known to have previous adverse reaction to human albumin solution
- Patients who have religious restriction to receive human blood products
- Patient who have initial graft failure
- Patients with fluctuating hemodynamics
- Concerns of the treating surgeon
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to try to identify the dominant physiological mechanism so that we will be able to better identify patients that may benefit from the use of albumin (25%) boluses in addition to standard care in patients following liver transplantation.
- Conditions
- Other Complications of Liver Transplant
- Being tested
- Saline, 25% albumin
- Keywords
- Liver, transplant, albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.
25% albuminDrug
100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Saline | Active comparator | Not described Receives: Drug: Saline |
| 25% albumin | Experimental | Not described Receives: Drug: 25% albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index (CI)
Measured: 60 minutes after the infusion of the fluid
Secondary outcomes (4)
Cardiac function response
An improvement in Q due primarily to a change in cardiac function should have an increase in Q of ≥ 0.3 ml/min/m2/mmHg
Measured: 30 and 60 minutes after the infusion of the fluid
A decrease in leak and plasma expansion
A decrease in leak and plasma expansion will be determined by the Harrison formula for calculating a change in plasma volume from the change in Hb and change in Hct
Measured: 30 and 60 minutes after the infusion of the fluid
Cardiac output response
Cardiac output response primarily due to a "volume effect" would be expected to have an increase of CVP of a minimum of 2 mmHg and an increase in CI of > 0.3 L/min/m2 per mmHg.
Measured: 30 and 60 minutes after the infusion of the fluid
Detoxification effect of albumin
A increase in vascular tone will be identified by an increase in systemic vascular resistance or a rise in blood pressure without a change in cardiac output or a rise in blood pressure with a fall in cardiac output
Measured: 30 and 60 minutes after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Complications of Liver TransplantStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- Investigators
- Sheldon Magder, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328132
- Sponsor's protocol ID
- 10-287-BMA
- Status last verified
- Jan 2011
- First submitted
- 31 Mar 2011
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant
- ClinicalTrials.gov ID
- NCT01328132
- Acronym / sponsor ID
- 10-287-BMA
- Conditions
- Other Complications of Liver Transplant
- Keywords
- Liver, transplant, albumin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 4 Apr 2011 (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 primary aim of this study is to assess the effect of hyperoncotic albumin on vascular hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to try to identify the dominant physiological mechanism so that we will be able to better identify patients that may benefit from the use of albumin (25%) boluses in addition to standard care in patients following liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Active comparator | Drug: Saline |
| 25% albumin | Experimental | Drug: 25% albumin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Patients from the Critical care Unit
- Patients with a pulmonary artery occlusion catheter Inclusion:patients immediately following liver transplantation
Key exclusion criteria (7 listed)
- Patients not giving informed consent
- Patients who have received > 300 ml of albumin within 24 hours prior to inclusion
- Patients known to have previous adverse reaction to human albumin solution
- Patients who have religious restriction to receive human blood products
- Patient who have initial graft failure
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 |
|---|---|---|
| Saline100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours. | Drug | Saline |
| 25% albumin100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours | Drug | 25% albumin |
Primary outcome
Cardiac index (CI)
Time frame: 60 minutes after the infusion of the fluid
4 secondary outcomes
Cardiac function response
Time frame: 30 and 60 minutes after the infusion of the fluid
A decrease in leak and plasma expansion
Time frame: 30 and 60 minutes after the infusion of the fluid
Cardiac output response
Time frame: 30 and 60 minutes after the infusion of the fluid
Detoxification effect of albumin
Time frame: 30 and 60 minutes after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
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.
Sheldon Magder, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline and 25% albumin in people with Other Complications of Liver Transplant, 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 4 Apr 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sheldon Magder, MD (514-934-1934 ext. 35253, sheldon.magder@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac index (CI) (time frame: 60 minutes after the infusion of the fluid). 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 4 Apr 2011.