Clinical trial

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

Name
AOP2414
Description
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)
Trial arms
Trial start
2022-07-01
Estimated PCD
2023-09-30
Trial end
2023-11-30
Status
Completed
Treatment
Crystalloids, albumin, vasoconstrictors, diuretics, renal replacement therapy
Adherence to International Club of Ascites recommendations for the management of AKI
Size
1456
Primary endpoint
90-day Mortality
90 days
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '90 Days', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1456, 'type': 'ACTUAL'}}
Updated at
2024-01-30

1 organization

1 product

3 indications

Indication
Cirrhosis