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

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].

Study Overview

• Status: Recruiting
• Conditions: Hepatorenal Syndrome
• Intervention / Treatment: Other: Hepatorenal Syndrome outcome in Patients at Methodist Health systems

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].

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Loretta W Bedell, MPH; Phone Number: 74680 214-947-4680; Email: mhsirb@mhd.com
• Study Contact Backup: Name: Colette Ngo Ndjom, MS; Phone Number: 71281 214-947-1281; Email: MHSIRB@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Liver Institute of Methodist Dallas Medical Center
      • Principal Investigator: Parvez Mantry, MD
      • Contact: Alejandro Mejia, MD; Phone Number: 214-947-4400; Email: ClinicalResearch@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome for HRS-AKI patients	Mortality rates, morbidities, complications, and other clinically relevant outcomes in HRS-AKI patients	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post transplant mortality rates	post-transplant mortality rates HRS-AKI-associated costs	4 years

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Parvez Mantry, MD, Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2023
• Primary Completion (Estimated): May 13, 2027
• Study Completion (Estimated): May 13, 2027

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Diseases; Liver Diseases; Hepatorenal Syndrome; Therapeutics; Surgical Procedures, Operative; Transplantation; Digestive System Surgical Procedures; Cell- and Tissue-Based Therapy; Biological Therapy; Tissue Transplantation; Organ Transplantation; Liver Transplantation
• Other Study ID Numbers: 020.HEP.2023.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No