A Retrospective Analysis of Outcomes in Patients with Hepatorenal Syndrome At Methodist Dallas Medical Center

Last updated: November 18, 2024
Sponsor: Methodist Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Failure

Treatment

Hepatorenal Syndrome outcome in Patients at Methodist Health systems

Clinical Study ID

NCT06095440
020.HEP.2023.D
  • Ages 18-85
  • All Genders

Study 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].

Eligibility Criteria

Inclusion

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 duringthe hospital course. HRS-AKI will be defined based on the ICA criteria, describedbelow:

  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 baselinevalue and/or urinary output ≤0.5 mL/kg of body weight for ≥6 hours (requiresuse of a urinary catheter)

  3. No full or partial response for ≥2 days of diuretic withdrawal and volumeexpansion 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

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.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Hepatorenal Syndrome outcome in Patients at Methodist Health systems
Phase:
Study Start date:
May 13, 2023
Estimated Completion Date:
May 13, 2025

Study 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].

Connect with a study center

  • Liver Institute of Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.