Korean Cohort Study of AKI & HRS in Cirrhosis

NCT ID: NCT03530761

Last Updated: 2018-05-21

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

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Cirrhosis Acute Kidney Injury Hepatorenal Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute kidney injury

Increase in serum creatinine more than 0.3 mg/dl within 48 hours or a percentage increase serum creatinine more than 50% from baseline.

No interventions assigned to this group

Hepatorenal syndrome

1. Diagnosis of cirrhosis and ascites,
2. Diagnosis of AKI according to ICA-AKI criteria
3. No response after 2 consecutive days of diuretic withdrawal and plasma volume expansion with albumin 1 g per kg of body weight
4. Absence of shock
5. No current or recent use of nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, iodinated contrast media, etc.)
6. No macroscopic signs of structural kidney injury, defined as: absence of proteinuria (\> 500 mg/day), absence of microhaematuria (\> 50 RBCs per high power field), normal findings on renal ultrasonography.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Gyune Kim

Associate proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Ju Yoo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

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SoonChunHyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong-Ju Yoo, Doctor

Role: CONTACT

82-10-9676-3128

Facility Contacts

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Sang Gyune Kim, Professor

Role: primary

82-32-621-5079

References

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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.

Reference Type RESULT
PMID: 27475248 (View on PubMed)

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.

Reference Type RESULT
PMID: 26042740 (View on PubMed)

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.

Reference Type RESULT
PMID: 26141259 (View on PubMed)

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.

Reference Type RESULT
PMID: 24700173 (View on PubMed)

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.

Reference Type RESULT
PMID: 26484442 (View on PubMed)

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.

Reference Type RESULT
PMID: 29369449 (View on PubMed)

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.

Reference Type RESULT
PMID: 24375576 (View on PubMed)

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.

Reference Type RESULT
PMID: 25183658 (View on PubMed)

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.

Reference Type RESULT
PMID: 22521351 (View on PubMed)

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.

Reference Type RESULT
PMID: 27876501 (View on PubMed)

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.

Reference Type RESULT
PMID: 24613364 (View on PubMed)

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.

Reference Type RESULT
PMID: 25638527 (View on PubMed)

Other Identifiers

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P-KAKI

Identifier Type: -

Identifier Source: org_study_id

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