Liver CirrhosisGLOBAL-AKINCT05387811
International Registry of Acute Kidney Injury in Cirrhosis: The GLOBAL AKI Project
An observational study of Liver Cirrhosis and Acute Kidney Injury, run by Azienda Ospedaliera di Padova at 38 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome
- What is being tested?
- Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapy
- How many people
- 1,456 participants
- Where
- 38 sitesin 21 countries
- Study dates
- 1 Jul 2022to 30 Nov 2023
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with cirrhosis admitted to hospital for the treatment of a complication of liver disease (ascites, gastrointestinal bleeding, hepatic encephalopathy, bacterial infections, jaundice, etc)
Who cannot join
- 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
Trial locations and contacts
38 sites in 21 countries.
38 sites in 21 countries
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22903
Baylor University Medical Center
Dallas, Texas, 75246
Indiana University
Indianapolis, Indiana, 46202
Ochsner Medical Center
New Orleans, Louisiana, 70121
Italy5 sites
IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna
Università La Sapienza - Latina
Latina
Hospital Niguarda Milan
Milan
University and Hospital of Padua
Padua, 35128
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Torino
Argentina4 sites
Hospital de Gastroenterología "Dr. Carlos Bonorino Udaondo"
Buenos Aires
Hospital Italiano
Buenos Aires
Hospital Nacional Prof. Alejandro Posadas
El Palomar
Universidad de Rosario
Rosario
Mexico3 sites
Central Military Hospital
Mexico City
Hospital General
Mexico City
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City
South Korea2 sites
Hallym University Sacred Heart Hospital
Anyang
Hallym University College of Medicine
Chuncheon
Paraguay1 site
Hospital de Clínicas Facultad de Ciencias Médicas U.N.A.
Asunción
About this study
Official title: Characteristics and Management of Acute Kidney Injury in Hospitalized Patients With Cirrhosis: a Multicenter Intercontinental Observational Prospective Study: The International Club of Ascites GLOBAL AKI Project
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:
- To establish the severity of AKI across different regions
- To identify precipitants of AKI across different centers
- To identify the phenotypes of AKI across different centers
- To evaluate differences in the management of AKI across different centers and their impact on clinical outcomes
- To assess outcomes of acute kidney injury (resolution of AKI, in-hospital mortality, 28-day mortality, 90-day mortality)
Read the 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
- Being tested
- Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapy
- Keywords
- AKI, International Club of Ascites, Cirrhosis, Global
- Medical subject headings
- Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapyCombination product
Adherence to International Club of Ascites recommendations for the management of AKI
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Mortality
Mortality at 90 days
Measured: 90 days
Secondary outcomes (8)
Phenotypes of acute kidney injury across geographic areas
Characteristics of acute kidney injury (clinical type and stage)
Measured: Hospital stay (up to 90 days)
Staging of acute kidney injury across geographic areas
Characteristics of acute kidney injury (clinical type and stage)
Measured: Hospital stay (up to 90 days)
Adherence to the International Club of Ascites recommendations for the management of AKI
Proportion of patients receiving treatment according to the International Club of Ascites recommmentations for the management of acute kidney injury
Measured: Hospital stay (up to 90 days)
Progression of AKI
Progression of AKI will be defined as transition of AKI to a higher stage and/or need for RRT.
Measured: Hospital stay (up to 90 days)
Resolution of AKI
Resolution of AKI will be defined as return of serum creatinine to a value within 0.3 mg/dl (26.5 mmol/L) of the baseline value. Partial response will be defined as regression of AKI to a lower stage with a reduction of serum creatinine to ≥0.3 mg/dl (26.5 mmol/L) above the baseline value
Measured: Hospital stay (up to 90 days)
In-hospital mortality
Mortality during hospital stay
Measured: Hospital stay (up to 90 days)
28-day mortality
Mortality at 28 days
Measured: 28 days
Development of CKD
Chronic kidney disease will be defined as an estimated glomerular filtration rate <60 ml/min ml/min/1.73 m2 for >3 months. The Modification of Diet in Renal Disease equation will be used for estimating glomerular filtration rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Jul 2022
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,456 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Piano, Azienda Ospedaliera di Padova
- Investigators
- Salvatore Piano, MD, Principal investigator, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387811
- Sponsor's protocol ID
- AOP2414
- Acronym
- GLOBAL-AKI
- Status last verified
- Jan 2024
- First submitted
- 16 May 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25638527Patidar 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.
PubMed 40058397
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Management of Acute Kidney Injury in Hospitalized Patients With Cirrhosis: a Multicenter Intercontinental Observational Prospective Study: The International Club of Ascites GLOBAL AKI Project
- ClinicalTrials.gov ID
- NCT05387811
- Acronym / sponsor ID
- GLOBAL-AKI / AOP2414
- Conditions
- Liver Cirrhosis, Acute Kidney Injury, Hepatorenal Syndrome
- Keywords
- AKI, International Club of Ascites, Cirrhosis, Global
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,456 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To establish the severity of AKI across different regions
- To identify precipitants of AKI across different centers
- To identify the phenotypes of AKI across different centers
- To evaluate differences in the management of AKI across different centers and their impact on clinical outcomes
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with cirrhosis admitted to hospital for the treatment of a complication of liver disease (ascites, gastrointestinal bleeding, hepatic encephalopathy, bacterial infections, jaundice, etc)
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapyAdherence to International Club of Ascites recommendations for the management of AKI | Combination product | – |
Primary outcome
90-day Mortality
Time frame: 90 days
Mortality at 90 days
8 secondary outcomes
Phenotypes of acute kidney injury across geographic areas
Time frame: Hospital stay (up to 90 days)
Staging of acute kidney injury across geographic areas
Time frame: Hospital stay (up to 90 days)
Adherence to the International Club of Ascites recommendations for the management of AKI
Time frame: Hospital stay (up to 90 days)
Progression of AKI
Time frame: Hospital stay (up to 90 days)
Resolution of AKI
Time frame: Hospital stay (up to 90 days)
In-hospital mortality
Time frame: Hospital stay (up to 90 days)
28-day mortality
Time frame: 28 days
Development of CKD
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Results publication: PubMed 25638527Angeli 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.
- Derived from this study: PubMed 40058397Patidar 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Piano, MD principal investigator
Azienda Ospedaliera di Padova
38 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Acute Kidney Injury, run by Azienda Ospedaliera di Padova at 38 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Italy, Argentina, Mexico, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.