Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0719
Source ID: NCT06161766
Associated Drug: Terlipressin Or Noradrenalin Plus Albumin
Title: Terlipressin in Combined Hepatorenal Syndrome in Patients With Signs of Chronic Renal Disease
Acronym: Terli-CKD
Status: COMPLETED
Study Results: NO
Results:
Conditions: Liver Cirrhosis|Hepato-Renal Syndrome|Chronic Kidney Diseases
Interventions: DRUG: terlipressin or noradrenalin plus albumin
Outcome Measures: Primary: Complete response to treatment with vasoactive drugs and albumin at the end of treatment, Complete response, as defined by a decrease of serum creatinine (SCr) to a value within 0.3 mg/dl (26.5 µmol/L) of the baseline value, at the end of vasoactive treatment., Through study completion, an average of 12 months | Secondary: Complete response to treatment with vasoactive drugs and albumin during follow-up, Complete response, as defined by a decrease of serum creatinine (SCr) to a value within 0.3 mg/dl (26.5 µmol/L) of the baseline value, at 3-months, 6-months and 12-months after treatment, Through study completion, an average of 12 months|Transplantation-free survival, Transplantation-free survival is defined as survival without need for liver transplantation, Through study completion, an average of 12 months|Partial response, at the end of vasoactive treatment, Partial response, at the end of vasoactive treatment defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26.5 µmol/L) of baseline value, Through study completion, an average of 12 months|In-hospital mortality, In-hospital mortality is defined as death during index hospitalization, Through study completion, an average of 12 months|90-day survival, 90-day survival is defined as survival assessed from beginning of hospitalization until 90 days after beginning of hospitalization, Within 90 days after beginning of hospitalization|Length of in-hospital-stay, Length of hospital stay is assessed from admission until discharge, Through study completion, an average of 12 months|Need for renal replacement therapy, Beginning of renal replacement therapy, Through study completion, an average of 12 months|Recurrence of suspected HRS-AKI after treatment, Recurrence of HRS-AKI, Through study completion, an average of 12 months|Complications of liver cirrhosis, Development of complications of liver cirrhosis, Through study completion, an average of 12 months|Acute-on chronic liver failure (ACLF), Development of complications of ACLF, Through study completion, an average of 12 months
Sponsor/Collaborators: Sponsor: University Hospital Freiburg | Collaborators: Jena University Hospital|Johannes Gutenberg University Mainz|University Hospital Muenster
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 490
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-03-15
Completion Date: 2024-12-01
Results First Posted:
Last Update Posted: 2024-12-09
Locations: University Medical Center Freiburg, Freiburg, Germany|University Medical center Jena, Jena, Germany|University Medical Center Mainz, Mainz, Germany|University Hospital Münster, Münster, Germany
URL: https://clinicaltrials.gov/show/NCT06161766