CompletedNo phase
International Registry of Acute Kidney Injury in Cirrhosis: The GLOBAL AKI Project
Key facts
- Who runs it
- Azienda Ospedaliera di Padova
- Where
- Boston, Charlottesville, Dallas, Indianapolis, and New Orleans, United StatesSee the 5 sitesAlso in 20 other countries, 33 sites
- Trial code
- Status
- Completed
- People taking part
- 1,456 people enrolled
- Started
- 1 Jul 2022
- Ended
- 30 Nov 2023
- Type of study
- Observational
- Treatments tested
- Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapy
- Record updated
- 30 January 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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 take part
- 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
- Patients who cannot provide prior informed consent and no legal surrogate decision maker
- Extrahepatic malignancy other than non-melanoma skin cancer within last 5 years
- HIV infection with CD4 ≤ 250/µL
- 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)
Where in United States
Also in 20 other countries, 33 sites
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- Baylor University Medical CenterDallas, United StatesNo longer taking part
- Indiana UniversityIndianapolis, United StatesNo longer taking part
- Ochsner Medical CenterNew Orleans, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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)
Treatments tested
- Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 30 January 2024