A Retrospective Analysis of Outcomes in Patients With Hepatorenal Syndrome at Methodist Dallas Medical Center

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorMethodist Health System

About this trial

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 patients leads to vasodilation, especially in the splanchnic circulation, resulting in hemodynamic changes that precipitate renal injury \[1\]. Patients may present with elevated serum creatinine (Cr), benign urine sediment, and low urine sodium \[1\].

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

\- 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)

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Hepatorenal Syndrome outcome in Patients at Methodist Health systems

    Other intervention

    1.2.1. To perform a retrospective analysis of patients with HRS with the aim of comparing various treatment modalities such as vasoconstrictors, albumin, CRRT, Molecular Adsorbent Recirculating System (MARS), and TIPS.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Primary Outcome for HRS-AKI patients

Mortality rates, morbidities, complications, and other clinically relevant outcomes in HRS-AKI patients

Time frame
4 years

Secondary outcomes

1

post transplant mortality rates

post-transplant mortality rates HRS-AKI-associated costs

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.