Overall survival
Time frame · up to 3 years
From date of sample collection until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Korean Cohort Study of AKI & HRS in Cirrhosis
Status
Unknown
Phase
Not applicable
Enrollment
245
Locations
1
Results
Not posted
Publications
12
Study summary
What the protocol is testing.
The aim of this study is to investigate i) whether two biomarkers (urine NAG, urinary cystatin C) could be predictive factor in patient with liver cirrhosis, , and ii) whether these biomarkers can predict response of terlipressin.
Full detailed description
Acute kidney injury (AKI) in patients with liver cirrhosis is sometimes accompanied by tubular injury which can lead to poor outcome. Current AKI criteria using serum creatinine (Cr) has some limitations to predict reversibility of renal function and discriminate renal parenchymal injury in cirrhotic patients. The aim of this study is to evaluate whether urine biomarkers \[cystatin C, N-acetyl-β-D-Glucosaminidase (NAG)\] can predict survival and response to terlipressin in cirrhotic patients with AKI.
Interventions
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
May 21, 2018
Study start
Aug 1, 2017
Primary completion
Dec 31, 2018
Study completion
Dec 31, 2019
Results posted
Not reported
Registry updated
May 21, 2018
Outcomes
What the study measures.
Primary outcomes
Secondary outcomes
Transplantation free survival
Time frame · up to 3 years
From date of sample collection until the date of first liver transplantation or date of death from any cause, whichever came first, assessed up to 3 years
Regression of acute kidney injury
Time frame · up to 1 month
Regression is defined as movement of AKI to a lower stage and decrease of serum creatinine
Recurrence of acute kidney injury
Time frame · up to 1 year
From sample collection day to elevation day of creatinine
Progression to chronic kidney disease
Time frame · 1 year
From sample collection day to progression to CKD
Response rate to terlipressin
Time frame · 1 week
If reduction of creatinine 0.3mg/dL from the baseline
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome * Patients who voluntarily agreed to the study Exclusion Criteria: * Patients with active bleeding (eg, varix bleeding) within 7 days * Patients with hepatocellular carcinoma * Patients with hypersensitivity to terlipressin * Patients with anuria * Pregnant and lactating patients * Patients who did not agree with the study
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
SoonChunHyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Publications
Results and literature.
PMID 27475248 ↗Helmersson-Karlqvist J, Arnlov J, Carlsson AC, Lind L, Larsson A. Urinary KIM-1, but not urinary cystatin C, should be corrected for urinary creatinine. Clin Biochem. 2016 Oct;49(15):1164-1166. doi: 10.1016/j.clinbiochem.2016.07.015. Epub 2016 Jul 28.PMID 26042740 ↗Ariza X, Sola E, Elia C, Barreto R, Moreira R, Morales-Ruiz M, Graupera I, Rodriguez E, Huelin P, Sole C, Fernandez J, Jimenez W, Arroyo V, Gines P. Analysis of a urinary biomarker panel for clinical outcomes assessment in cirrhosis. PLoS One. 2015 Jun 4;10(6):e0128145. doi: 10.1371/journal.pone.0128145. eCollection 2015.PMID 26141259 ↗Angeli P, Tonon M, Pilutti C, Morando F, Piano S. Sepsis-induced acute kidney injury in patients with cirrhosis. Hepatol Int. 2016 Jan;10(1):115-23. doi: 10.1007/s12072-015-9641-1. Epub 2015 Jul 4.PMID 24700173 ↗Wong F, Murray P. Kidney damage biomarkers: Novel tools for the diagnostic assessment of acute kidney injury in cirrhosis. Hepatology. 2014 Aug;60(2):455-7. doi: 10.1002/hep.27063. Epub 2014 Jun 18. No abstract available.PMID 26484442 ↗Wong F. The evolving concept of acute kidney injury in patients with cirrhosis. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):711-9. doi: 10.1038/nrgastro.2015.174. Epub 2015 Oct 20.PMID 29369449 ↗Jaques DA, Spahr L, Berra G, Poffet V, Lescuyer P, Gerstel E, Garin N, Martin PY, Ponte B. Biomarkers for acute kidney injury in decompensated cirrhosis: A prospective study. Nephrology (Carlton). 2019 Feb;24(2):170-180. doi: 10.1111/nep.13226.PMID 24375576 ↗Belcher JM, Sanyal AJ, Peixoto AJ, Perazella MA, Lim J, Thiessen-Philbrook H, Ansari N, Coca SG, Garcia-Tsao G, Parikh CR; TRIBE-AKI Consortium. Kidney biomarkers and differential diagnosis of patients with cirrhosis and acute kidney injury. Hepatology. 2014 Aug;60(2):622-32. doi: 10.1002/hep.26980. Epub 2014 Jun 26.PMID 25183658 ↗Belcher JM, Garcia-Tsao G, Sanyal AJ, Thiessen-Philbrook H, Peixoto AJ, Perazella MA, Ansari N, Lim J, Coca SG, Parikh CR; TRIBE-AKI Consortium. Urinary biomarkers and progression of AKI in patients with cirrhosis. Clin J Am Soc Nephrol. 2014 Nov 7;9(11):1857-67. doi: 10.2215/CJN.09430913. Epub 2014 Sep 2.PMID 22521351 ↗Fagundes C, Pepin MN, Guevara M, Barreto R, Casals G, Sola E, Pereira G, Rodriguez E, Garcia E, Prado V, Poch E, Jimenez W, Fernandez J, Arroyo V, Gines P. Urinary neutrophil gelatinase-associated lipocalin as biomarker in the differential diagnosis of impairment of kidney function in cirrhosis. J Hepatol. 2012 Aug;57(2):267-73. doi: 10.1016/j.jhep.2012.03.015. Epub 2012 Apr 17.PMID 27876501 ↗Yap DY, Seto WK, Fung J, Chok SH, Chan SC, Chan GC, Yuen MF, Chan TM. Serum and urinary biomarkers that predict hepatorenal syndrome in patients with advanced cirrhosis. Dig Liver Dis. 2017 Feb;49(2):202-206. doi: 10.1016/j.dld.2016.11.001. Epub 2016 Nov 10.PMID 24613364 ↗Barreto R, Elia C, Sola E, Moreira R, Ariza X, Rodriguez E, Graupera I, Alfaro I, Morales-Ruiz M, Poch E, Guevara M, Fernandez J, Jimenez W, Arroyo V, Gines P. Urinary neutrophil gelatinase-associated lipocalin predicts kidney outcome and death in patients with cirrhosis and bacterial infections. J Hepatol. 2014 Jul;61(1):35-42. doi: 10.1016/j.jhep.2014.02.023. Epub 2014 Mar 5.PMID 25638527 ↗Angeli P, Gines P, Wong F, Bernardi M, Boyer TD, Gerbes A, Moreau R, Jalan R, Sarin SK, Piano S, Moore K, Lee SS, Durand F, Salerno F, Caraceni P, Kim WR, Arroyo V, Garcia-Tsao G. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. J Hepatol. 2015 Apr;62(4):968-74. doi: 10.1016/j.jhep.2014.12.029. Epub 2015 Jan 28. No abstract available.
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