Renal Insufficiency, AcuteNCT00855127
New Urine and Blood Markers for Acute Kidney Injury in Liver Transplant Patients
An observational study of Renal Insufficiency, Acute, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Insufficiency, Acute
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Jul 2013
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to the University of Colorado Hospital or the University of Washington Medical Center for a liver transplant operation
Who may be able to join
- First time liver transplant recipient
- Cadaveric or living donor livers
Who cannot join
- Unconscious patients or patients who cannot give consent
- Pregnant women
- Prisoners
- Patients receiving dialysis before or during liver transplant operation
- Patients receiving simultaneous liver-kidney transplants
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Washington
Seattle, Washington, 98105
About this study
Official title: Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients
The purpose of this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.
Read the detailed description
Patients with end stage liver disease that receive a liver transplant will be studied to determine if novel serum and urine biomarkers (serum cystatin C, urine interleukin-18 [IL-18] and urine neutrophil gelatinase associated lipocalin [NGAL]) can predict the outcome measures listed above.
- Conditions
- Renal Insufficiency, Acute
- Keywords
- Biological Markers, Renal Replacement Therapy, Mortality
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of acute kidney injury as defined by a 50% increase in serum creatinine
Measured: Within 2 to 5 days of liver transplant that is sustained for at least 24 hours
Secondary outcomes (3)
Development of severe acute kidney injury, as defined as a doubling of serum creatinine
Measured: Within 2-5 days of transplant that is sustained for at least 24 hours
The need for renal replacement therapy
Measured: After liver transplant operation to discharge
All cause mortality
Measured: After liver transplant operation to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2013
- Study completionJul 2013
Why it stopped: no enrollment
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 Renal Insufficiency, AcuteStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Denver Health Medical Center, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Angela M Walcher, MD, Principal investigator, University of Colorado, DenverCharles L Edelstein, MD, PhD, Study director, University of Colorado, DenverConnie L Davis, MD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855127
- Sponsor's protocol ID
- 08-0769
- Status last verified
- May 2015
- First submitted
- 3 Mar 2009
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Edelstein CL. Biomarkers of acute kidney injury. Adv Chronic Kidney Dis. 2008 Jul;15(3):222-34. doi: 10.1053/j.ackd.2008.04.003.
PubMed 18565474Parikh CR, Mishra J, Thiessen-Philbrook H, Dursun B, Ma Q, Kelly C, Dent C, Devarajan P, Edelstein CL. Urinary IL-18 is an early predictive biomarker of acute kidney injury after cardiac surgery. Kidney Int. 2006 Jul;70(1):199-203. doi: 10.1038/sj.ki.5001527. Epub 2006 May 17.
PubMed 16710348Parikh CR, Abraham E, Ancukiewicz M, Edelstein CL. Urine IL-18 is an early diagnostic marker for acute kidney injury and predicts mortality in the intensive care unit. J Am Soc Nephrol. 2005 Oct;16(10):3046-52. doi: 10.1681/ASN.2005030236. Epub 2005 Sep 7.
PubMed 16148039
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Biomarkers of Acute Kidney Injury in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT00855127
- Acronym / sponsor ID
- 08-0769
- Conditions
- Renal Insufficiency, Acute
- Keywords
- Biological Markers, Renal Replacement Therapy, Mortality
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Washington, Denver Health Medical Center, Children's Hospital Medical Center, Cincinnati
- Study start
- Jan 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Mar 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 this study is to find new blood and urine tests that detect acute kidney injury earlier than our current blood tests in patients receiving a liver transplant.
Detailed description
Patients with end stage liver disease that receive a liver transplant will be studied to determine if novel serum and urine biomarkers (serum cystatin C, urine interleukin-18 [IL-18] and urine neutrophil gelatinase associated lipocalin [NGAL]) can predict the outcome measures listed above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant recipients | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to the University of Colorado Hospital or the University of Washington Medical Center for a liver transplant operation
Key inclusion criteria (2 listed)
- First time liver transplant recipient
- Cadaveric or living donor livers
Key exclusion criteria (5 listed)
- Unconscious patients or patients who cannot give consent
- Pregnant women
- Prisoners
- Patients receiving dialysis before or during liver transplant operation
- Patients receiving simultaneous liver-kidney transplants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of acute kidney injury as defined by a 50% increase in serum creatinine
Time frame: Within 2 to 5 days of liver transplant that is sustained for at least 24 hours
3 secondary outcomes
Development of severe acute kidney injury, as defined as a doubling of serum creatinine
Time frame: Within 2-5 days of transplant that is sustained for at least 24 hours
The need for renal replacement therapy
Time frame: After liver transplant operation to discharge
All cause mortality
Time frame: After liver transplant operation to discharge
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 1 Jun 2015.
- Background: PubMed 18565474Edelstein CL. Biomarkers of acute kidney injury. Adv Chronic Kidney Dis. 2008 Jul;15(3):222-34. doi: 10.1053/j.ackd.2008.04.003.
- Background: PubMed 16710348Parikh CR, Mishra J, Thiessen-Philbrook H, Dursun B, Ma Q, Kelly C, Dent C, Devarajan P, Edelstein CL. Urinary IL-18 is an early predictive biomarker of acute kidney injury after cardiac surgery. Kidney Int. 2006 Jul;70(1):199-203. doi: 10.1038/sj.ki.5001527. Epub 2006 May 17.
- Background: PubMed 16148039Parikh CR, Abraham E, Ancukiewicz M, Edelstein CL. Urine IL-18 is an early diagnostic marker for acute kidney injury and predicts mortality in the intensive care unit. J Am Soc Nephrol. 2005 Oct;16(10):3046-52. doi: 10.1681/ASN.2005030236. Epub 2005 Sep 7.
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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.
Angela M Walcher, MD principal investigator
University of Colorado, Denver
Charles L Edelstein, MD, PhD study director
University of Colorado, Denver
Connie L Davis, MD study director
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Acute, run by University of Colorado, Denver at 2 sites 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 2 inclusion and 5 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Development of acute kidney injury as defined by a 50% increase in serum creatinine (time frame: Within 2 to 5 days of liver transplant that is sustained for at least 24 hours). 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 NCT00855127, 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 1 Jun 2015.