Analysis of outcomes in patients with Hepatorenal Syndrome
A Retrospective Analysis of Outcomes in Patients With Hepatorenal Syndrome at Methodist Dallas Medical Center
This study looks at how patients with Hepatorenal Syndrome are doing over four years to see how different treatments affect their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Methodist Health System Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06095440 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes the outcomes of patients diagnosed with Hepatorenal Syndrome (HRS) at Methodist Dallas Medical Center over a four-year period. It focuses on patients who presented with HRS-AKI or developed HRS during their hospital stay, assessing their clinical characteristics and treatment responses. The study aims to identify patterns and outcomes associated with different classifications of HRS, including the impact of interventions like continuous renal replacement therapy and transjugular intrahepatic portosystemic shunts. By reviewing patient records, the study seeks to enhance understanding of HRS management in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients over 18 years old who have been diagnosed with HRS-AKI or developed HRS during their hospital stay.
Not a fit: Patients under 18 years old or those who do not meet the criteria for HRS-AKI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and treatment strategies for patients suffering from Hepatorenal Syndrome.
How similar studies have performed: While there have been studies on Hepatorenal Syndrome, this specific retrospective analysis is novel in its approach to understanding outcomes at a single institution.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. Presence of cirrhosis, acute liver failure, or acute-on-chronic liver failure 2. 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) 3. 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) 4. Absence of shock 5. No current or recent treatment with nephrotoxic drugs 6. Absence of parenchymal renal disease 7. Suggestion of renal vasoconstriction based on FENa \<0.2% Exclusion Criteria: * 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.
Where this trial is running
Dallas, Texas
- Liver Institute of Methodist Dallas Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Parvez Mantry, MD — Methodist Health System
- Study coordinator: Colette Ngo Ndjom, MS
- Email: MHSIRB@mhd.com
- Phone: 214-947-1281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.