Clinical trial NCT06095440: A Retrospective Analysis of Outcomes in Patients with Hepatorenal Syndrome At Methodist Dallas Medical Center
Official title: A Retrospective Analysis of Outcomes in Patients with Hepatorenal Syndrome At Methodist Dallas Medical Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatorenal Syndrome
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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)

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 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 \[1\].

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:

  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.

Primary outcomes:
measure: Primary Outcome for HRS-AKI patients
timeFrame: 4 years
Secondary outcomes:
measure: post transplant mortality rates
timeFrame: 4 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Liver Institute of Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Parvez Mantry, MD
role: PRINCIPAL_INVESTIGATOR
References: