Korean Cohort Study of AKI & HRS in Cirrhosis

NCT03530761 | Unknown

• 1 other identifier: P-KAKI
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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

  up to 3 years

Secondary Outcomes (5)

• Transplantation free survival

  up to 3 years

• Regression of acute kidney injury

  up to 1 month

• Recurrence of acute kidney injury

  up to 1 year

• Progression to chronic kidney disease

  1 year

• Response rate to terlipressin

  1 week

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome

You may qualify if:

• Patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome
• Patients who voluntarily agreed to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

SoonChunHyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

RECRUITING

Related Publications (12)

• 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: 27475248 RESULT

• 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: 26042740 RESULT

• 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: 26141259 RESULT

• 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: 24700173 RESULT

• 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: 26484442 RESULT

• 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: 29369449 RESULT

• 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: 24375576 RESULT

• 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: 25183658 RESULT

• 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: 22521351 RESULT

• 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: 27876501 RESULT

• 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: 24613364 RESULT

• 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.

  PMID: 25638527 RESULT

MeSH Terms

Conditions

Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jeong-Ju Yoo, Doctor

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Ju Yoo, Doctor

CONTACT

82-10-9676-3128; puby17@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffesor

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 21, 2018
• Study Start: August 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

KR (1)