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

NCT05387811 | Completed DMC

• 1 other identifier: AOP2414
• Study Type: observational
• Target: 1,456
• Locations: 21 countries
• Sites: 38

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. 1.To establish the severity of AKI across different regions
2. 2.To identify precipitants of AKI across different centers
3. 3.To identify the phenotypes of AKI across different centers
4. 4.To evaluate differences in the management of AKI across different centers and their impact on clinical outcomes
5. 5.To assess outcomes of acute kidney injury (resolution of AKI, in-hospital mortality, 28-day mortality, 90-day mortality)

Conditions

Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome

Keywords

AKI; International Club of Ascites; Cirrhosis; Global

Outcome Measures

Primary Outcomes (1)

• 90-day Mortality

  Mortality at 90 days

  90 days

Secondary Outcomes (8)

• Phenotypes of acute kidney injury across geographic areas

  Hospital stay (up to 90 days)

• Staging of acute kidney injury across geographic areas

  Hospital stay (up to 90 days)

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

  Hospital stay (up to 90 days)

• Progression of AKI

  Hospital stay (up to 90 days)

• Resolution of AKI

  Hospital stay (up to 90 days)

Other Outcomes (4)

• Transfer to intensive care unit

  Hospital stay (up to 90 days)

• Mechanical ventilation

  Hospital stay (up to 90 days)

• Renal replacement therapy

  Hospital stay (up to 90 days)

Interventions

Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapy COMBINATION_PRODUCT

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

Eligibility Criteria

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

Study Population

Patients with cirrhosis admitted to hospital for the treatment of a complication of liver disease (ascites, gastrointestinal bleeding, hepatic encephalopathy, bacterial infections, jaundice, etc) Patients without AKI will enter in a screening period during the hospitalization to identify patients with hospital-acquired AKI. For patients that will not develop AKI during hospitalization, no other visits will be performed during the study, except for the discharge and follow-up visits.

You may qualify if:

• 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)

You may not qualify if:

• Age \< 18 years old;
• Pregnancy;
• 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);
• Extrahepatic malignancy other than non-melanoma skin cancer within last 5 years;
• 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);
• Previous solid organ transplantation;
• HIV infection with CD4 ≤ 250/µL;
• Patients who cannot provide prior informed consent and no legal surrogate decision maker

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (38)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Hospital de Gastroenterología "Dr. Carlos Bonorino Udaondo"

Buenos Aires, Argentina

Location

Hospital Italiano

Buenos Aires, Argentina

Location

Hospital Nacional Prof. Alejandro Posadas

El Palomar, Argentina

Location

Universidad de Rosario

Rosario, Argentina

Location

Hospital Federal de Bonsoccesso

Rio de Janeiro, Brazil

Location

Universidad de Chile

Santiago, Chile

Location

Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Ain Shams University

Cairo, Egypt

Location

Black Lion Hospital

Addis Ababa, Ethiopia

Location

Jean Minjoz University Hospital

Besançon, France

Location

Hospital Beaujon

Clichy, France

Location

University of Aachen

Aachen, Germany

Location

University Hospital Munich

Munich, Germany

Location

Hospital of Debrecen

Debrecen, Hungary

Location

Institute of Liver and Biliary Sciences

New Delhi, India

Location

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Italy

Location

Università La Sapienza - Latina

Latina, Italy

Location

Hospital Niguarda Milan

Milan, Italy

Location

University and Hospital of Padua

Padua, 35128, Italy

Location

Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

Torino, Italy

Location

Central Military Hospital

Mexico City, Mexico

Location

Hospital General

Mexico City, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

Mexico City, Mexico

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

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

Asunción, Paraguay

Location

Hospital Nacional D.A. Carrion

Lima, Peru

Location

Medical University of Warsaw

Warsaw, Poland

Location

University of Moscow

Moscow, Russia

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Hallym University College of Medicine

Chuncheon, South Korea

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital Vall D'Hebron

Barcelona, Spain

Location

Related Publications (2)

• 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

• 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.

  PMID: 40058397 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome; Fibrosis

Interventions

Crystalloid Solutions; Albumins; Vasoconstrictor Agents; Diuretics; Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; 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

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations; Proteins; Amino Acids, Peptides, and Proteins; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Natriuretic Agents; Physiological Effects of Drugs; Therapeutics

Study Officials

• Salvatore Piano, MD

  Azienda Ospedaliera di Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 24, 2022
• Study Start: July 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1); BR (1); FR (2); DE (2); ME (3); RU (1); AR (4); ES (2); PL (1); EG (1); CL (1); PA (1); KR (2); US (5); NL (1); PE (1); HU (1); IN (1); DK (1); ET (1); IT (5)