Status:
RECRUITING
A Retrospective Analysis of Outcomes in Patients with Hepatorenal Syndrome At Methodist Dallas Medical Center
Lead Sponsor:
Methodist Health System
Conditions:
Hepatorenal Syndrome
Eligibility:
All Genders
18-85 years
Brief Summary
Hepatorenal syndrome (HRS) is a common cause of acute kidney injury (AKI) in patients with liver disease \[1\]. Increased activity and presence of vasodilators such as nitric oxide in cirrhotic patien...
Detailed Description
There are two main classifications of HRS: HRS-AKI (previously known as type 1 HRS) and diuretic-resistant ascites (previously known as type 2 HRS) \[1\]. The ultimate treatment for patients with HRS...
Eligibility Criteria
Inclusion
- All patients \>18 years old that were hospitalized between April 1st 2019 and April 1st 2023 who either presented with HRS-AKI or developed a diagnosis of HRS during the hospital course. HRS-AKI will be defined based on the ICA criteria, described below:
- Presence of cirrhosis, acute liver failure, or acute-on-chronic liver failure
- An increase in serum Cr of ≥0.3 mg/dL within 48 hours or ≥50% from baseline value and/or urinary output ≤0.5 mL/kg of body weight for ≥6 hours (requires use of a urinary catheter)
- No full or partial response for ≥2 days of diuretic withdrawal and volume expansion with albumin (dosed at 1 g/kg of body weight/day)
- Absence of shock
- No current or recent treatment with nephrotoxic drugs
- Absence of parenchymal renal disease
- Suggestion of renal vasoconstriction based on FENa \<0.2%
Exclusion
- 1\. HRS-AKI patients \<18 years of age 2. All patients hospitalized between April 1st 2019 and April 1st 2023 without a diagnosis of HRS-AKI.
Key Trial Info
Start Date :
May 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 13 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06095440
Start Date
May 13 2023
End Date
May 13 2025
Last Update
November 20 2024
Active Locations (1)
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1
Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, United States, 75203