Acute Kidney InjuryNCT01619449
Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant
A study testing Renal replacement therapy in people with Acute Kidney Injury and Liver Disease, run by University of Chicago at 1 site in United States.
Trial summary
To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Liver Disease, Chronic Kidney Disease
- What is being tested?
- Renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older and able to sign consent (or surrogate)
- Receiving liver or combined liver-kidney transplant
- eGFR < or equal to 40 ml/min immediately prior to transplant or currently on any form of renal replacement therapy for acute kidney injury or end-stage renal disease
- Pre-operative potassium of < or equal to 5.5 mEq/L
Who cannot join
- Pre-operative hemoglobin < or equal to 7 g/dL
- Pre-operative weight > or equal to 125 kig
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant: A Randomized Trial
To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters. The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is associated with increased solute removal and improved acid-base statues when compared to controls who do not receive CRRT
Read the detailed description
as above
- Being tested
- Renal replacement therapy
- Keywords
- Acute Kidney Injury, Continuous Renal Replacement Therapy, Liver Transplant
- Medical subject headings
- Acute Kidney Injury, Liver Diseases, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal replacement therapyProcedure or surgery
Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.
| Study group | Role | What they receive |
|---|---|---|
| Renal replacement therapy | Experimental | Liver transplant recipients who receive continuous renal replacement therapy intra-operatively. Receives: Procedure: Renal replacement therapy |
| No CRRT | Active comparator | This arm consists of standard of care without CRRT in the OR for OLT Receives: Procedure: Renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solute Clearance
To compare the clearance of solutes (ie. potassium, lactate, creatinine and blood urea nitrogen) by CRRT in renally impaired OLT recipients to OLT recipients who do not receive CRRT
Measured: Intra-operative time
Secondary outcomes (1)
Renal function and patient outcomes
To compare long-term maintenance of renal function (12 months) and other health outcomes in OLT recipients who received CRRT versus OLT recipients who did not receive OLT
Measured: 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Research never begun and no subjects enrolled. Protocol term with IRB in Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay L Koyner, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619449
- Sponsor's protocol ID
- IRB #11-0626
- Status last verified
- May 2015
- First submitted
- 12 Jun 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01619449
- Acronym / sponsor ID
- IRB #11-0626
- Keywords
- Acute Kidney Injury, Continuous Renal Replacement Therapy, Liver Transplant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research never begun and no subjects enrolled. Protocol term with IRB in Dec 2014
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Jun 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.
To evaluate the efficacy of continuous renal replacement therapy (CRRT) during orthotopic liver transplantation (OLT) in clearing excess solutes and improving acid-base parameters. The investigators hypothesize that the use of intra-operative CRRT in OLT recipients is associated with increased solute removal and improved acid-base statues when compared to controls who do not receive CRRT
Detailed description
as above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal replacement therapy | Experimental | Procedure: Renal replacement therapyLiver transplant recipients who receive continuous renal replacement therapy intra-operatively. |
| No CRRT | Active comparator | Procedure: Renal replacement therapyThis arm consists of standard of care without CRRT in the OR for OLT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older and able to sign consent (or surrogate)
- Receiving liver or combined liver-kidney transplant
- eGFR < or equal to 40 ml/min immediately prior to transplant or currently on any form of renal replacement therapy for acute kidney injury or end-stage renal disease
- Pre-operative potassium of < or equal to 5.5 mEq/L
Key exclusion criteria (2 listed)
- Pre-operative hemoglobin < or equal to 7 g/dL
- Pre-operative weight > or equal to 125 kig
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 |
|---|---|---|
| Renal replacement therapyLiver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery. | Procedure or surgery | No CRRT, Renal replacement therapy |
Primary outcome
Solute Clearance
Time frame: Intra-operative time
To compare the clearance of solutes (ie. potassium, lactate, creatinine and blood urea nitrogen) by CRRT in renally impaired OLT recipients to OLT recipients who do not receive CRRT
1 secondary outcome
Renal function and patient outcomes
Time frame: 1 year post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Jay L Koyner, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal replacement therapy in people with Acute Kidney Injury and Liver Disease, run by University of Chicago at 1 site in United States.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 27 May 2015. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Solute Clearance (time frame: Intra-operative time). 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 May 2015.