Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT06095440

Conditions

Hepatorenal Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hepatorenal Syndrome outcome in Patients at Methodist Health systems

Study Details

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 \[1\].

Conditions

Hepatorenal Syndrome

Study ID

NCT06095440

Start date

May 13, 2023

Status verified date

Apr, 2026

Completion date

May 13, 2027

Anticipated

Primary completion date

May 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Colette Ngo Ndjom, MS

214-947-1281MHSIRB@mhd.com

Loretta W Bedell, MPH

214-947-4680mhsirb@mhd.com

Locations

Liver Institute of Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Principal Investigator:

Parvez Mantry, MD

More Information

Sponsor

Methodist Health System

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Methodist Health System on 2026-05-01.