[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556478":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":27,"centralContacts":27,"locations":40,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":27,"enrollmentInfo":83,"targetDuration":27,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":27,"overallStatus":42,"whyStopped":27,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"VAGA Group","EXPERIMENTAL","This group will receive an algorithm-based recommendation based on the 2024 Acute Disease Quality Initiative (ADQI)\u002FInternational Club of Ascites (ICA) joint consensus meeting on AKI in cirrhosis, which recommends a personalized approach to AKI in cirrhosis in order to avoid volume overload. This includes balanced crystalloids as first-line resuscitative fluids unless there is a patient-specific indication for an alternative colloid (e.g. blood for gastrointestinal bleeding, IV albumin for spontaneous bacterial peritonitis or suspicion of hepatorenal syndrome), or no further resuscitation.",[13,14,15],"Other: Recommendation: No Further Resuscitation","Other: Recommendation: Resuscitation with Crystalloid","Other: Recommendation: Resuscitation with Colloid",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard of Care","PLACEBO_COMPARATOR","This group will receive a recommendation based on the 2021 American Association for the Study of Liver Diseases (AASLD) and 2018 European Association for the Study of the Liver (EASL) clinical practice guidelines, which recommends a 1 g\u002Fkg\u002Fd IV albumin (maximum 100 g\u002Fday) IV albumin over 2 days as an initial resuscitation approach for patients with AKI and cirrhosis.",[21],"Other: Recommendation: Standard of Care IV Albumin",[23,28,32,36],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Recommendation: No Further Resuscitation","Treatment teams are encouraged not to administer any additional fluids",[9],null,{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Recommendation: Resuscitation with Crystalloid","Treatment teams are encouraged to administer crystalloid. Amount of resuscitative fluid will be determined by treatment team's clinical assessments and usual standards of care",[9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Recommendation: Resuscitation with Colloid","Treatment teams are encouraged to administer colloid. Amount of resuscitative fluid will be determined by treatment team's clinical assessments and usual standards of care",[9],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Recommendation: Standard of Care IV Albumin","Treatment teams are encouraged to administer 1 g\u002Fkg\u002Fd IV albumin (maximum 100 g\u002Fday) over 2 days",[17],[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-71.05977,42.35843,{"lat":52,"lon":51},[55,60,63],{"name":56,"role":57,"phone":58,"phoneExt":27,"email":59},"Sydney Whittaker, BS","CONTACT","6177263465","swhittaker3@mgh.harvard.edu",{"name":61,"role":57,"phone":27,"phoneExt":27,"email":62},"Andrew S Allegretti, MD, MSc","aallegretti@mgh.harvard.edu",{"name":64,"role":65,"phone":27,"phoneExt":27,"email":27},"Andrew S Allegretti, MD Msc","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Andrew S. Allegretti, MD, MSC","Director of Critical Care Nephrology",[70],{"name":71,"class":72},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100556478","initial-resuscitation-for-acute-kidney-injury-in-cirrhosis-100556478",false,"NCT06525623","Initial Resuscitation for Acute Kidney Injury in Cirrhosis","Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis: A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm","RAKI-VAGA","Inclusion Criteria:\n\n1. Adult age 18 years or greater\n2. Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally authorized representatives prior to initiation of any study procedures.\n3. Admitted to the hospital\n4. Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).\n5. Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg\u002FdL within 48 hours or ≥50% increase from baseline which is known or presumed to have occurred within the prior 7 days.\n\nExclusion Criteria:\n\n1. Requiring \\>2 liters (L) supplemental oxygen at the time of screening.\n2. In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).\n3. Allergy or other contraindication to IV albumin administration.\n4. Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.\n5. Patient and\u002For legally authorized representative unable to provide informed consent.\n6. Hepatic encephalopathy grade 3 or 4 at the time of screening.\n7. Already received \\>200 g albumin during admission at the time of screening.\n8. Severe, active bleeding requiring 3 or more units of red blood cell transfusion in the 48 hours prior to screening.\n9. Admission to the intensive care unit at the time of screening.\n10. Mechanical ventilation at the time of screening.\n11. Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.\n12. History of prior liver or kidney transplant.\n13. Pregnant or nursing status\n14. Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.","ALL","18 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin?\n\nPatients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.",[91,92,93],"Cirrhosis, Liver","Acute Kidney Injury","Hepatorenal Syndrome","2026-03-11",{"date":96,"type":97},"2026-03-13","ACTUAL",{"date":99,"type":97},"2024-09-12",{"date":101,"type":85},"2027-05-01",{"name":5,"class":6},1]