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

NCT06095440 | Recruiting DMC

• 1 other identifier: 020.HEP.2023.D
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Primary Outcome for HRS-AKI patients

  Mortality rates, morbidities, complications, and other clinically relevant outcomes in HRS-AKI patients

  4 years

Secondary Outcomes (1)

• post transplant mortality rates

  4 years

Interventions

Hepatorenal Syndrome outcome in Patients at Methodist Health systems OTHER

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.

Also known as: liver transplantation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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%

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Liver Institute of Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Hepatorenal Syndrome

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Parvez Mantry, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette Ngo Ndjom, MS

CONTACT

214-947-1281; MHSIRB@mhd.com

Loretta W Bedell, MPH

CONTACT

214-947-4680; mhsirb@mhd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: October 23, 2023
• Study Start: May 13, 2023
• Primary Completion (Estimated): May 13, 2027
• Study Completion (Estimated): May 13, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)