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NCT Number: NCT06095440

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].

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liver Institute of Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location status: Recruiting

Location contact

Alejandro Mejia, MD

CONTACT

[email protected]

214-947-4400

Parvez Mantry, MD

PRINCIPAL_INVESTIGATOR

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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%

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.

Treatment and study plan

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.

Other names: liver transplantation

Primary outcomes

  1. Primary Outcome for HRS-AKI patients

    Time frame: 4 years

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

Secondary outcomes

  1. post transplant mortality rates

    Time frame: 4 years

    post-transplant mortality rates HRS-AKI-associated costs

Study contacts

Contact information is provided by the study sponsor or research team.

Colette Ngo Ndjom, MS

CONTACT

[email protected]

214-947-1281 ext. 71281

Loretta W Bedell, MPH

CONTACT

[email protected]

214-947-4680 ext. 74680

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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