International Registry of Acute Kidney Injury in Cirrhosis: The GLOBAL AKI Project

NCT ID: NCT05387811

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1456 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-11-30

Brief Summary

The aims of this study will be to identify the clinical characteristics, the management and the outcomes of acute kidney injury in patients with cirrhosis worldwide.

Specific aims:

1. To establish the severity of AKI across different regions

2. To identify precipitants of AKI across different centers

3. To identify the phenotypes of AKI across different centers

4. To evaluate differences in the management of AKI across different centers and their impact on clinical outcomes

5. To assess outcomes of acute kidney injury (resolution of AKI, in-hospital mortality, 28-day mortality, 90-day mortality)

Detailed Description

Each center will then include patients with cirrhosis who are admitted to the hospital with AKI upon admission or who develop AKI during the hospital stay, and who provide signed informed consent.

Acute kidney injury will be defined according to the International Club of Ascites Acute Kidney Injury criteria The following precipitating events of AKI will be considered: volume loss/excessive diuretic use, spontaneous bacterial peritonitis (SBP), non-SBP infection, gastrointestinal bleeding, nephrotoxic drugs (including nonsteroidal anti-inflammatory drugs, contrast media), other causes and no identifiable precipitant.

AKI will be classified in the following phenotypes:

• Hypovolemia-induced AKI: history of excessive fluid losses (i.e., excessive diuresis due to diuretic therapy with loss of body weight >500 g/day or 1,000 g/day in patients without and with edema, respectively; severe diarrhea) or bleeding the days before AKI and improving with fluid administration.
• HRS-AKI: all the following should be present: a) ascites; b) lack of regression of AKI to a lower stage or resolution of AKI after 2 days of diuretic withdrawal and volume expansion with albumin (1 g/kg of body weight per day to a maximum of 100 g/day); c) absence of shock; d) no current or recent treatment with nephrotoxic drugs; d) absence of parenchymal disease as indicated by proteinuria >500 mg/day, microhaematuria (>50 red blood cells per high power field), urinary injury biomarkers (if available) and/or abnormal renal ultrasonography.

Patients will be followed from admission until liver transplantation, death or 90 days, whichever occurs first. Data collected will include demographic, clinical and biochemical information, such as AKI severity, phenotype and evolution. There will be particular emphasis on collecting data regarding the initial management of AKI occurring in the first 2 to 3 days. Furthermore, basic demographic and disease information will be collected in hospitalized patients with cirrhosis who do not develop AKI during the stay to determine the true burden of AKI in this patient population.

Data will be registered on an electronic case report form (eCRF) using the Research Electronic Data Capture Software REDCap.

• ATN-AKI: presence of at least three out of six of the following criteria: a) FeNa > 2%; b) urinary osmolality <400 mOsm/L; c) urinary sodium > 40 mEq/L; d) presence of shock or use of nephrotoxic drugs; e) urine sediment showing granular/epithelial casts; f) urine sediment showing renal tubular epithelial cells.
• Other parenchymal nephropathy: patients with signs of parenchymal nephropathy not qualified for a diagnosis of ATN-AKI (e.g. IgA nephropathy, glomerulonephritis, nephrotic syndrome, etc.)
• Post renal AKI: AKI caused by urinary tract obstruction (kidney/bladder stones, prostatic hyperplasia) and resolved after removal of obstruction
• Unclassified/other AKI: Other types of AKI not fulfilling the afore mentioned phenotypes

Conditions

Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapy

Adherence to International Club of Ascites recommendations for the management of AKI

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

a) Patients with cirrhosis admitted to hospital for the treatment of a complication of liver disease (ascites, gastrointestinal bleeding, hepatic encephalopathy, bacterial infections, jaundice, etc)

Exclusion Criteria

1. Age < 18 years old;

2. Pregnancy;

3. Hepatocellular carcinoma outside Milan criteria (i.e., a single lesion <5 cm or multiple lesions [maximum of three], the largest of which measures ≤ 3 cm);

4. Extrahepatic malignancy other than non-melanoma skin cancer within last 5 years;

5. Previously known severe extrahepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe congestive heart disease [NYHA class ≥ 3]; severe chronic obstructive pulmonary disease [GOLD class ≥ 3], psychiatric disorders);

6. Previous solid organ transplantation;

7. HIV infection with CD4 ≤ 250/µL;

8. Patients who cannot provide prior informed consent and no legal surrogate decision maker

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera di Padova

OTHER

Sponsor Role: lead

Responsible Party

Salvatore Piano

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salvatore Piano, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera di Padova

Locations

Indiana University

Indianapolis, Indiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Hospital de Gastroenterología "Dr. Carlos Bonorino Udaondo"

Buenos Aires, , Argentina

Hospital Italiano

Buenos Aires, , Argentina

Hospital Nacional Prof. Alejandro Posadas

El Palomar, , Argentina

Universidad de Rosario

Rosario, , Argentina

Hospital Federal de Bonsoccesso

Rio de Janeiro, , Brazil

Universidad de Chile

Santiago, , Chile

Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Hvidovre Hospital

Copenhagen, , Denmark

Ain Shams University

Cairo, , Egypt

Black Lion Hospital

Addis Ababa, , Ethiopia

Jean Minjoz University Hospital

Besançon, , France

Hospital Beaujon

Clichy, , France

University of Aachen

Aachen, , Germany

University Hospital Munich

Munich, , Germany

Hospital of Debrecen

Debrecen, , Hungary

Institute of Liver and Biliary Sciences

New Delhi, , India

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, , Italy

Università La Sapienza - Latina

Latina, , Italy

Hospital Niguarda Milan

Milan, , Italy

University and Hospital of Padua

Padua, , Italy

Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

Torino, , Italy

Central Military Hospital

Mexico City, , Mexico

Hospital General

Mexico City, , Mexico

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, , Mexico

Erasmus Medical Center

Rotterdam, , Netherlands

Hospital de Clínicas Facultad de Ciencias Médicas U.N.A.

Asunción, , Paraguay

Hospital Nacional D.A. Carrion

Lima, , Peru

Medical University of Warsaw

Warsaw, , Poland

University of Moscow

Moscow, , Russia

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Hallym University College of Medicine

Chuncheon, , South Korea

Hospital Clinic

Barcelona, , Spain

Hospital Vall D'Hebron

Barcelona, , Spain

Countries

United States; Argentina; Brazil; Chile; China; Denmark; Egypt; Ethiopia; France; Germany; Hungary; India; Italy; Mexico; Netherlands; Paraguay; Peru; Poland; Russia; South Korea; Spain

References

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)

Patidar KR, Ma AT, Juanola A, Barone A, Incicco S, Kulkarni AV, Hernandez JLP, Wentworth B, Asrani SK, Alessandria C, Abdelkader NA, Wong YJ, Xie Q, Pyrsopoulos NT, Kim SE, Fouad Y, Torre A, Cerda E, Ferrer JD, Maiwall R, Simonetto DA, Papp M, Orman ES, Perricone G, Sole C, Lange CM, Farias AQ, Pereira G, Gadano A, Caraceni P, Thevenot T, Verma N, Kim JH, Vorobioff JD, Cordova-Gallardo J, Ivashkin V, Roblero JP, Maan R, Toledo C, Gioia S, Fassio E, Marino M, Nabilou P, Vargas V, Merli M, Goncalves LL, Rabinowich L, Krag A, Balcar L, Montes P, Mattos AZ, Bruns T, Mohammed A, Laleman W, Carrera E, Cabrera MC, Girala M, Samant H, Raevens S, Madaleno J, Kim RW, Arab JP, Presa J, Ferreira CN, Galante A, Allegretti AS, Takkenberg B, Marciano S, Sarin SK, Durand F, Gines P, Angeli P, Sola E, Piano S; International Club of Ascites GLOBAL AKI team. Global epidemiology of acute kidney injury in hospitalised patients with decompensated cirrhosis: the International Club of Ascites GLOBAL AKI prospective, multicentre, cohort study. Lancet Gastroenterol Hepatol. 2025 May;10(5):418-430. doi: 10.1016/S2468-1253(25)00006-8. Epub 2025 Mar 6.

Reference Type: DERIVED

PMID: 40058397 (View on PubMed)

Other Identifiers

AOP2414

Identifier Type: -

Identifier Source: org_study_id