Liver FailureINCEPTIONNCT01575015
Intraoperative Dialysis in Liver Transplantation
A study testing Continuous renal replacement therapy (CRRT) and Standard intraoperative support in people with Liver Failure and Acute Kidney Disease, run by University of Alberta at 1 site in Canada.
Trial summary
Patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. These patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Acute Kidney Disease, Multi-organ Failure
- What is being tested?
- Continuous renal replacement therapy (CRRT) and Standard intraoperative support
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to 11 Dec 2015
- 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
- Consent
- Adult (age > 18 years on the day of assessment of eligibility)
- Planned cadaveric orthotopic liver transplantation
- Pre-operative unadjusted (natural) Modification of End-Stage Liver Disease (MELD) score > 25.
- Pre-operative AKI, defined by a minimum RIFLE-RISK, AND/OR pre-operative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.
Who cannot join
- Planned living-related donor liver transplantation
- Pre-operative potassium [K] > 4.5 mmol/L AND urine output < 100 mL in the 6 hrs preceding assessment of eligibility
- Pre-operative pH < 7.3
Trial locations and contacts
1 site in 1 country.
Canada1 site
Division of Critical Care Medicine, University of Alberta Hospital
Edmonton, Alberta, T6G2B7
About this study
Official title: Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)
Patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. These patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. As a consequence, these patients are at an increased risk for complications related to their kidney failure during their liver transplantation procedure. One potential method to diminish the risk of these complications is to provide dialysis support to these patients during their liver transplantation in the operating theater in the form of continuous renal replacement therapy (CRRT). While this is increasingly being performed and is theoretically appealing, there is very little information to support this practice. In addition, the use of CRRT during surgery is not entirely without risk. The investigators have performed two preliminary studies on the use of CRRT during liver transplantation and our data would strongly support the need to conduct further higher-quality studies to better evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial comparing the use of CRRT during surgery with standard supportive care in sick patients with liver failure scheduled to receive a liver transplantation.
- Conditions
- Liver Failure, Acute Kidney Disease, Multi-organ Failure
- Being tested
- Continuous renal replacement therapy (CRRT), Standard intraoperative support
- Keywords
- Liver transplantation (E04.210.650), Renal replacement therapy (E05.196.353), Intra-operative period (E04.614.374), Safety (N06.850.135.060.075), Efficacy
- Medical subject headings
- Liver Failure, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous renal replacement therapy (CRRT)Device
Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation
Standard intraoperative supportProcedure or surgery
Patients allocated to standard intraoperative support will receive usual care (no CRRT).
| Study group | Role | What they receive |
|---|---|---|
| Standard intraoperative support (no CRRT) | Active comparator | Not described Receives: Procedure: Standard intraoperative support |
| Intraoperative renal support (CRRT) | Experimental | Not described Receives: Device: Continuous renal replacement therapy (CRRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients adhering to the prescribed protocol
Will be defined as the proportion of patients adhering to the prescribed protocol.
Measured: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
Number of patients with adverse events
This will be defined by the proportion of patients experiencing intra-operative adverse events, serious adverse events and complications related to the study intervention.
Measured: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
Secondary outcomes (6)
Fluid balance
Will be defined as the changes in fluid accumulation intra- and post-operatively.
Measured: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Number of patients with post-operative graft dysfunction
Graft dysfunction will include post-operative ultrasonographic-evidence of vascular ischemia/occlusion or venous occlusion; biliary stricture, obstruction or anastomosis leak; primary non-function; biopsy-proven rejection; or need for surgical re-exploration for any reason.
Measured: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Number of patients with post-operative kidney dysfunction
Will be defined as post-operative acute kidney injury, defined by RIFLE criteria; along with encompassing receipt of renal replacement therapy (RRT).
Measured: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Length of stay
Will include ICU and hospital lengths of stay
Measured: From the date of liver transplant until the date of discharge from ICU/hospital
Mortality
Mortality through 90-days.
Measured: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Number of patients readmitted to hospital within 90-days
Will be defined as hospital re-admission within 90-days of liver transplant for any cause.
Measured: From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMay 2012
- Primary completion11 Dec 2015
- Study completion11 Dec 2015
Why it stopped: Insufficient funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean M Bagshaw, University of Alberta
- Investigators
- Sean M Bagshaw, MD, MSc, Principal investigator, Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575015
- Sponsor's protocol ID
- UOFAPro00026047
- Acronym
- INCEPTION
- Status last verified
- Feb 2017
- First submitted
- 25 Mar 2012
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Townsend DR, Bagshaw SM, Jacka MJ, Bigam D, Cave D, Gibney RT. Intraoperative renal support during liver transplantation. Liver Transpl. 2009 Jan;15(1):73-8. doi: 10.1002/lt.21650.
PubMed 19109832Parmar A, Bigam D, Meeberg G, Cave D, Townsend DR, Gibney RT, Bagshaw SM. An evaluation of intraoperative renal support during liver transplantation: a matched cohort study. Blood Purif. 2011;32(3):238-48. doi: 10.1159/000329485. Epub 2011 Aug 9.
PubMed 21829016Karvellas CJ, Taylor S, Bigam D, Kneteman NM, Shapiro AMJ, Romanovsky A, Gibney RTN, Townsend DR, Meeberg G, Ozelsel T, Bishop E, Bagshaw SM. Intraoperative continuous renal replacement therapy during liver transplantation: a pilot randomized-controlled trial (INCEPTION). Can J Anaesth. 2019 Oct;66(10):1151-1161. doi: 10.1007/s12630-019-01454-0. Epub 2019 Jul 26.
PubMed 31350701
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Operative Continuous Renal Replacement Therapy in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION)
- ClinicalTrials.gov ID
- NCT01575015
- Acronym / sponsor ID
- INCEPTION / UOFAPro00026047
- Conditions
- Liver Failure, Acute Kidney Disease, Multi-organ Failure
- Keywords
- Liver transplantation (E04.210.650), Renal replacement therapy (E05.196.353), Intra-operative period (E04.614.374), Safety (N06.850.135.060.075), Efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 11 Dec 2015 (actual)
- Study completion
- 11 Dec 2015 (actual)
- First posted
- 10 Apr 2012 (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.
Patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. These patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. As a consequence, these patients are at an increased risk for complications related to their kidney failure during their liver transplantation procedure. One potential method to diminish the risk of these complications is to provide dialysis support to these patients during their liver transplantation in the operating theater in the form of continuous renal replacement therapy (CRRT). While this is increasingly being performed and is theoretically appealing, there is very little information to support this practice. In addition, the use of CRRT during surgery is not entirely without risk. The investigators have performed two preliminary studies on the use of CRRT during liver transplantation and our data would strongly support the need to conduct further higher-quality studies to better evaluate its feasibility, safety and usefulness. Our proposed study is for a randomized trial comparing the use of CRRT during surgery with standard supportive care in sick patients with liver failure scheduled to receive a liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard intraoperative support (no CRRT) | Active comparator | Procedure: Standard intraoperative support |
| Intraoperative renal support (CRRT) | Experimental | Device: Continuous renal replacement therapy (CRRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consent
- Adult (age > 18 years on the day of assessment of eligibility)
- Planned cadaveric orthotopic liver transplantation
- Pre-operative unadjusted (natural) Modification of End-Stage Liver Disease (MELD) score > 25.
- Pre-operative AKI, defined by a minimum RIFLE-RISK, AND/OR pre-operative estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, calculated by the Modification of Diet in Renal Disease (MDRD) equation.
Key exclusion criteria (3 listed)
- Planned living-related donor liver transplantation
- Pre-operative potassium [K] > 4.5 mmol/L AND urine output < 100 mL in the 6 hrs preceding assessment of eligibility
- Pre-operative pH < 7.3
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 |
|---|---|---|
| Continuous renal replacement therapy (CRRT)Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation | Device | Intraoperative renal support (CRRT) |
| Standard intraoperative supportPatients allocated to standard intraoperative support will receive usual care (no CRRT). | Procedure or surgery | Standard intraoperative support (no CRRT) |
Primary outcome
Number of patients adhering to the prescribed protocol
Time frame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
Will be defined as the proportion of patients adhering to the prescribed protocol.
Number of patients with adverse events
Time frame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)
This will be defined by the proportion of patients experiencing intra-operative adverse events, serious adverse events and complications related to the study intervention.
6 secondary outcomes
Fluid balance
Time frame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Number of patients with post-operative graft dysfunction
Time frame: In-hospital (patients will be followed for duration of post-operative hospital stay, anticipated average 4 weeks post-operatively)
Number of patients with post-operative kidney dysfunction
Time frame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Length of stay
Time frame: From the date of liver transplant until the date of discharge from ICU/hospital
Mortality
Time frame: From the date of liver transplant until the date of first documented outcome of interest, assessed until 90-days
Number of patients readmitted to hospital within 90-days
Time frame: From the date of liver transplant after hospital discharge, until the date of first documented re-admission to hospital, assessed until 90-days
Results and safety
The study was stopped early (reason given: Insufficient funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 19109832Townsend DR, Bagshaw SM, Jacka MJ, Bigam D, Cave D, Gibney RT. Intraoperative renal support during liver transplantation. Liver Transpl. 2009 Jan;15(1):73-8. doi: 10.1002/lt.21650.
- Background: PubMed 21829016Parmar A, Bigam D, Meeberg G, Cave D, Townsend DR, Gibney RT, Bagshaw SM. An evaluation of intraoperative renal support during liver transplantation: a matched cohort study. Blood Purif. 2011;32(3):238-48. doi: 10.1159/000329485. Epub 2011 Aug 9.
- Derived from this study: PubMed 31350701Karvellas CJ, Taylor S, Bigam D, Kneteman NM, Shapiro AMJ, Romanovsky A, Gibney RTN, Townsend DR, Meeberg G, Ozelsel T, Bishop E, Bagshaw SM. Intraoperative continuous renal replacement therapy during liver transplantation: a pilot randomized-controlled trial (INCEPTION). Can J Anaesth. 2019 Oct;66(10):1151-1161. doi: 10.1007/s12630-019-01454-0. Epub 2019 Jul 26.
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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.
Sean M Bagshaw, MD, MSc principal investigator
Division of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous renal replacement therapy (CRRT) and Standard intraoperative support in people with Liver Failure and Acute Kidney Disease, run by University of Alberta 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Feb 2017. 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?
The study was stopped early (reason given: Insufficient funding.). Results are not available in the source record.
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?
Number of patients adhering to the prescribed protocol (time frame: Intra-operative (From the induction of anesthesia to trasnfer from the OR to the ICU, average 6-8 hours)). The study lists 2 primary outcomes in all. 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 NCT01575015, which also lists 3 linked publications.
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 7 Feb 2017.