Clinical trial NCT02095431: Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation
Official title: Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Keywords: patients undergoing the liver transplantation
acute kidney injury
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-03-24
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to liver transplantation .

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.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Reception liver transplantation

Exclusion Criteria:

* CKD stage 4 / 5
* Combined organ transplants
* Patients receiving dialysis before liver transplant operation

Primary outcomes:
measure: Development of Acute Kidney Injury based on novel biomarkers
timeFrame: within 7 days
Secondary outcomes:
measure: Short and long term renal outcomes
timeFrame: 1 year
measure: Association of urine chemistry and microscopy to predict acute kidney injury
timeFrame: within 7 days of liver transplantation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: Faculty of Medicine, University of São Paulo
name: Etienne Macedo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Feldkamp 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.
citation: White 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.
citation: Tsagalis G. Update of acute kidney injury: intensive care nephrology. Hippokratia. 2011 Jan;15(Suppl 1):53-68.
citation: Macedo 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.
citation: Nejat 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.
citation: Sirota JC, Klawitter J, Edelstein CL. Biomarkers of acute kidney injury. J Toxicol. 2011;2011:328120. doi: 10.1155/2011/328120. Epub 2011 Oct 29.
citation: Xu 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.
citation: Mehta 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.
citation: Lima 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.