Clinical Trials Logo

Clinical 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. 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)

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05387811
Study type Observational [Patient Registry]
Source Azienda Ospedaliera di Padova
Contact Salvatore Piano, MD
Phone +390498212265
Email [email protected]
Status Recruiting
Start date July 1, 2022
Completion date December 30, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05033652 - Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust N/A
Completed NCT03938038 - Guidance of Ultrasound in Intensive Care to Direct Euvolemia N/A
Recruiting NCT04986137 - Fractional Excretion of Urea for the Differential Diagnosis of Acute Kidney Injury in Cirrhosis
Recruiting NCT04293744 - Acute Kidney Injury After Cardiac Surgery N/A
Active, not recruiting NCT04095143 - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Terminated NCT03438877 - Intensive Versus Regular Dosage For PD In AKI. N/A
Terminated NCT03305549 - Recovery After Dialysis-Requiring Acute Kidney Injury N/A
Enrolling by invitation NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Terminated NCT02860130 - Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT) Phase 3
Completed NCT02665377 - Prevention of Akute Kidney Injury, Hearttransplant, ANP Phase 3
Recruiting NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A
Not yet recruiting NCT04523064 - iSGLT2 in Prevention of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing CABG Extracorporeal On-Pump Phase 4
Recruiting NCT05214729 - A Net Ultrafiltration Challenge to Predict Preload-dependence (UF CHALLENGE) N/A
Not yet recruiting NCT05283213 - Development of an Innovative Clinico-biological Score for the Early Detection of Acute Renal Failure Associated With Cardiac Surgery.
Not yet recruiting NCT05017896 - Prediction of Acute Kidney Injury After Operation of Acute Type A Aortic Dissection Based on Multimodal Model
Not yet recruiting NCT04952714 - RRT With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock
Recruiting NCT02976792 - Effectiveness of the NephroCheck™ After TAVI N/A
Recruiting NCT02914782 - Investigation of Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients
Active, not recruiting NCT01720030 - Levosimendan in Acute Kidney Injury Study Phase 2/Phase 3
Completed NCT02518087 - Increased Adsorption Membranes During Cardiopulmonary Bypass N/A