Acute Kidney Injury Biomarkers: Diagnosis and Application in Pre-operative Period of Liver Transplantation

NCT ID: NCT02095431

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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with AKI and without AKI

development of AKI by sCr and by novel biomarkers

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Etienne Macedo

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Etienne Macedo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, University of São Paulo

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 19399734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21486868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21826270 (View on PubMed)

Tsagalis G. Update of acute kidney injury: intensive care nephrology. Hippokratia. 2011 Jan;15(Suppl 1):53-68.

Reference Type BACKGROUND
PMID: 21897760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19855270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22418979 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22131986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20525552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17331245 (View on PubMed)

Lima 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.

Reference Type DERIVED
PMID: 39287102 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31615452 (View on PubMed)

Other Identifiers

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2013/12710-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

10393

Identifier Type: -

Identifier Source: org_study_id

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