Acute Kidney InjuryAKIBNCT02095431
Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation
An observational study of Acute Kidney Injury, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Acute kidney injury (AKI), is a common complication of patients undergoing liver transplantation. Timing and definition of AKI, usually based on serum creatinine, have been inaccurate and inconsistent. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 122 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Aug 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to liver transplantation .
Who may be able to join
- Older than 18 years
- Reception liver transplantation
Who cannot join
- CKD stage 4 / 5
- Combined organ transplants
- Patients receiving dialysis before liver transplant operation
Trial locations and contacts
1 site in 1 country.
About this study
Acute kidney injury (AKI), is a common complication of patients undergoing liver transplantation. Timing and definition of AKI, usually based on serum creatinine, have been inaccurate and inconsistent.
We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to provide information on the risk of progression of AKI, the need for RRT and mortality.
- Conditions
- Acute Kidney Injury
- Keywords
- patients undergoing the liver transplantation, acute kidney injury
- 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 |
|---|---|---|
| with AKI and without AKI | development of AKI by sCr and by novel biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Acute Kidney Injury based on novel biomarkers
Compare the timing for diagnosis of AKI comparing novel biomarkers and serum creatinine defined by Kidney Disease Improving Global Outcomes. In addition, we aim to evaluate if the pattern of elevation of the novel biomarkers provide information on progression and severity of AKI.
Measured: within 7 days
Secondary outcomes (2)
Short and long term renal outcomes
renal function and need for RRT
Measured: 1 year
Association of urine chemistry and microscopy to predict acute kidney injury
Association of urine chemistry and microscopy with novel biomarkers to predict AKI diagnosis and progression
Measured: within 7 days of liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Etienne Macedo, University of Sao Paulo
- Investigators
- Etienne Macedo, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095431
- Sponsor's protocol ID
- 10393
- Other IDs
- 2013/12710-2
- Acronym
- AKIB
- Status last verified
- May 2016
- First submitted
- 7 Feb 2014
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Barri YM, Sanchez EQ, Jennings LW, Melton LB, Hays S, Levy MF, Klintmalm GB. Acute kidney injury following liver transplantation: definition and outcome. Liver Transpl. 2009 May;15(5):475-83. doi: 10.1002/lt.21682.
PubMed 19399734Feldkamp T, Bienholz A, Kribben A. Urinary neutrophil gelatinase-associated lipocalin (NGAL) for the detection of acute kidney injury after orthotopic liver transplantation. Nephrol Dial Transplant. 2011 May;26(5):1456-8. doi: 10.1093/ndt/gfr146. Epub 2011 Apr 12. No abstract available.
PubMed 21486868White LE, Hassoun HT. Inflammatory Mechanisms of Organ Crosstalk during Ischemic Acute Kidney Injury. Int J Nephrol. 2012;2012:505197. doi: 10.4061/2012/505197. Epub 2011 Jun 9.
PubMed 21826270Tsagalis G. Update of acute kidney injury: intensive care nephrology. Hippokratia. 2011 Jan;15(Suppl 1):53-68.
PubMed 21897760Macedo E, Mehta RL. Prerenal failure: from old concepts to new paradigms. Curr Opin Crit Care. 2009 Dec;15(6):467-73. doi: 10.1097/MCC.0b013e328332f6e3.
PubMed 19855270Nejat M, Pickering JW, Devarajan P, Bonventre JV, Edelstein CL, Walker RJ, Endre ZH. Some biomarkers of acute kidney injury are increased in pre-renal acute injury. Kidney Int. 2012 Jun;81(12):1254-62. doi: 10.1038/ki.2012.23. Epub 2012 Mar 14.
PubMed 22418979Sirota JC, Klawitter J, Edelstein CL. Biomarkers of acute kidney injury. J Toxicol. 2011;2011:328120. doi: 10.1155/2011/328120. Epub 2011 Oct 29.
PubMed 22131986Xu X, Ling Q, Wei Q, Wu J, Gao F, He ZL, Zhou L, Zheng SS. An effective model for predicting acute kidney injury after liver transplantation. Hepatobiliary Pancreat Dis Int. 2010 Jun;9(3):259-63.
PubMed 20525552Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
PubMed 17331245Lima C, Santos Ferreira G, Vattimo MFF, de Paiva Haddad LB, Malbouisson LM, Carneiro D'Albuquerque LA, Maciel AT, Macedo E. Comprehensive biomarker assessment for predicting severe acute kidney injury and need of kidney replacement therapy in liver transplantation patients. Ren Fail. 2024 Dec;46(2):2402076. doi: 10.1080/0886022X.2024.2402076. Epub 2024 Sep 17.
PubMed 39287102Lima C, de Paiva Haddad LB, de Melo PDV, Malbouisson LM, do Carmo LPF, D'Albuquerque LAC, Macedo E. Early detection of acute kidney injury in the perioperative period of liver transplant with neutrophil gelatinase-associated lipocalin. BMC Nephrol. 2019 Oct 15;20(1):367. doi: 10.1186/s12882-019-1566-9.
PubMed 31615452
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation
- ClinicalTrials.gov ID
- NCT02095431
- Acronym / sponsor ID
- AKIB / 10393
- Conditions
- Acute Kidney Injury
- Keywords
- patients undergoing the liver transplantation, acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 24 Mar 2014 (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.
Acute kidney injury (AKI), is a common complication of patients undergoing liver transplantation. Timing and definition of AKI, usually based on serum creatinine, have been inaccurate and inconsistent.
We hypothesized that the pattern of novel biomakers elevation could be a prognostic tool to provide information on the risk of progression of AKI, the need for RRT and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| with AKI and without AKI | – | –development of AKI by sCr and by novel biomarkers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to liver transplantation .
Key inclusion criteria (2 listed)
- Older than 18 years
- Reception liver transplantation
Key exclusion criteria (3 listed)
- CKD stage 4 / 5
- Combined organ transplants
- Patients receiving dialysis before liver transplant operation
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 based on novel biomarkers
Time frame: within 7 days
Compare the timing for diagnosis of AKI comparing novel biomarkers and serum creatinine defined by Kidney Disease Improving Global Outcomes. In addition, we aim to evaluate if the pattern of elevation of the novel biomarkers provide information on progression and severity of AKI.
2 secondary outcomes
Short and long term renal outcomes
Time frame: 1 year
Association of urine chemistry and microscopy to predict acute kidney injury
Time frame: within 7 days of liver transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Background: PubMed 19399734Barri YM, Sanchez EQ, Jennings LW, Melton LB, Hays S, Levy MF, Klintmalm GB. Acute kidney injury following liver transplantation: definition and outcome. Liver Transpl. 2009 May;15(5):475-83. doi: 10.1002/lt.21682.
- Background: PubMed 21486868Feldkamp T, Bienholz A, Kribben A. Urinary neutrophil gelatinase-associated lipocalin (NGAL) for the detection of acute kidney injury after orthotopic liver transplantation. Nephrol Dial Transplant. 2011 May;26(5):1456-8. doi: 10.1093/ndt/gfr146. Epub 2011 Apr 12. No abstract available.
- Background: PubMed 21826270White LE, Hassoun HT. Inflammatory Mechanisms of Organ Crosstalk during Ischemic Acute Kidney Injury. Int J Nephrol. 2012;2012:505197. doi: 10.4061/2012/505197. Epub 2011 Jun 9.
- Background: PubMed 21897760Tsagalis G. Update of acute kidney injury: intensive care nephrology. Hippokratia. 2011 Jan;15(Suppl 1):53-68.
- Background: PubMed 19855270Macedo E, Mehta RL. Prerenal failure: from old concepts to new paradigms. Curr Opin Crit Care. 2009 Dec;15(6):467-73. doi: 10.1097/MCC.0b013e328332f6e3.
- Background: PubMed 22418979Nejat M, Pickering JW, Devarajan P, Bonventre JV, Edelstein CL, Walker RJ, Endre ZH. Some biomarkers of acute kidney injury are increased in pre-renal acute injury. Kidney Int. 2012 Jun;81(12):1254-62. doi: 10.1038/ki.2012.23. Epub 2012 Mar 14.
- Background: PubMed 22131986Sirota JC, Klawitter J, Edelstein CL. Biomarkers of acute kidney injury. J Toxicol. 2011;2011:328120. doi: 10.1155/2011/328120. Epub 2011 Oct 29.
- Background: PubMed 20525552Xu X, Ling Q, Wei Q, Wu J, Gao F, He ZL, Zhou L, Zheng SS. An effective model for predicting acute kidney injury after liver transplantation. Hepatobiliary Pancreat Dis Int. 2010 Jun;9(3):259-63.
- Background: PubMed 17331245Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
- Derived from this study: PubMed 39287102Lima C, Santos Ferreira G, Vattimo MFF, de Paiva Haddad LB, Malbouisson LM, Carneiro D'Albuquerque LA, Maciel AT, Macedo E. Comprehensive biomarker assessment for predicting severe acute kidney injury and need of kidney replacement therapy in liver transplantation patients. Ren Fail. 2024 Dec;46(2):2402076. doi: 10.1080/0886022X.2024.2402076. Epub 2024 Sep 17.
- Derived from this study: PubMed 31615452Lima C, de Paiva Haddad LB, de Melo PDV, Malbouisson LM, do Carmo LPF, D'Albuquerque LAC, Macedo E. Early detection of acute kidney injury in the perioperative period of liver transplant with neutrophil gelatinase-associated lipocalin. BMC Nephrol. 2019 Oct 15;20(1):367. doi: 10.1186/s12882-019-1566-9.
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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.
Etienne Macedo, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University of Sao Paulo at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 17 May 2016. 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 Brazil. 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?
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 based on novel biomarkers (time frame: within 7 days). 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 NCT02095431, which also lists 11 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 17 May 2016.