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

Overview

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 \[1\].

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 is to improve hepatic function via treatment of underlying etiology or liver transplantation; however, this is not always immediately possible due to the high demand for liver transplantation among other factors \[1\]. Continuous renal replacement therapy (CRRT) can also be considered, especially in patients with severe electrolyte derangements such as hypokalemia or pulmonary edema, that are not responding to medical therapy \[1\]. Often, CRRT is used as a bridging therapy to stabilize patients until they are optimized for receiving a liver transplant \[1, 2\]. CRRT, however, comes with its own risks and disadvantages such as hypotension and increased risk of cardiac adverse events \[2\]. In certain cases, transjugular intrahepatic portosystemic shunts (TIPS) can benefit patients with HRS by reducing portal pressure resulting in increase in renal perfusion \[1\].

Interventions

• Other Hepatorenal Syndrome outcome in Patients at Methodist Health systems
  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.

Primary outcome measures

• Primary Outcome for HRS-AKI patients [Time frame: 4 years]

Secondary outcome measures (1)

• post transplant mortality rates [Time frame: 4 years]

Eligibility 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:

• 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Liver Institute of Methodist Dallas Medical Center — Dallas

Identifiers

NCT: NCT06095440 · 020.HEP.2023.D

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗