An observational study in Liver Cirrhosis, Acute Kidney Injury and Hepatorenal Syndrome, sponsored by Azienda Ospedaliera di Padova. Completed at 38 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Azienda Ospedaliera di Padova · Observational
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:
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:
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 1,456 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Azienda Ospedaliera di Padova is the lead sponsor of 38 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adherence to International Club of Ascites recommendations for the management of AKI
90-day Mortality
Mortality at 90 days
Time frame: 90 days
Phenotypes of acute kidney injury across geographic areas
Characteristics of acute kidney injury (clinical type and stage)
Time frame: Hospital stay (up to 90 days)
Staging of acute kidney injury across geographic areas
Characteristics of acute kidney injury (clinical type and stage)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Hospital stay (up to 90 days)
In-hospital mortality
Mortality during hospital stay
Time frame: Hospital stay (up to 90 days)
28-day mortality
Mortality at 28 days
Time frame: 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
Time frame: 90 days
Transfer to intensive care unit
Transfer to intensive care unit
Time frame: Hospital stay (up to 90 days)
Mechanical ventilation
Patients receiving mechanical ventilation
Time frame: Hospital stay (up to 90 days)
Renal replacement therapy
Patients receiving renal replacement therapy
Time frame: Hospital stay (up to 90 days)
Indication to RRT
Patients with indications to receive renal replacement therapy
Time frame: Hospital stay (up to 90 days)
Plan to share: Undecided
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera di Padova