Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation
AKIB
2 other identifiers
observational
122
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedMay 17, 2016
May 1, 2016
2 years
February 7, 2014
May 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
within 7 days
Secondary Outcomes (2)
Short and long term renal outcomes
1 year
Association of urine chemistry and microscopy to predict acute kidney injury
within 7 days of liver transplantation
Study Arms (1)
with AKI and without AKI
development of AKI by sCr and by novel biomarkers
Eligibility Criteria
Patients submitted to liver transplantation .
You may qualify if:
- Older than 18 years
- Reception liver transplantation
You may not qualify if:
- CKD stage 4 / 5
- Combined organ transplants
- Patients receiving dialysis before liver transplant operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
São Paulo, São Paulo, 05320000, Brazil
Related Publications (11)
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.
PMID: 19399734BACKGROUNDFeldkamp 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.
PMID: 21486868BACKGROUNDWhite 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.
PMID: 21826270BACKGROUNDTsagalis G. Update of acute kidney injury: intensive care nephrology. Hippokratia. 2011 Jan;15(Suppl 1):53-68.
PMID: 21897760BACKGROUNDMacedo 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.
PMID: 19855270BACKGROUNDNejat 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.
PMID: 22418979BACKGROUNDSirota JC, Klawitter J, Edelstein CL. Biomarkers of acute kidney injury. J Toxicol. 2011;2011:328120. doi: 10.1155/2011/328120. Epub 2011 Oct 29.
PMID: 22131986BACKGROUNDXu 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.
PMID: 20525552BACKGROUNDMehta 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.
PMID: 17331245BACKGROUNDLima 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.
PMID: 39287102DERIVEDLima 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.
PMID: 31615452DERIVED
Biospecimen
blood plasma and urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Etienne Macedo, MD, PhD
Faculty of Medicine, University of São Paulo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 7, 2014
First Posted
March 24, 2014
Study Start
June 1, 2013
Primary Completion
June 1, 2015
Study Completion
August 1, 2016
Last Updated
May 17, 2016
Record last verified: 2016-05