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

Hepatorenal Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095440
• Other study ID #: 020.HEP.2023.D
• Status: Recruiting
• Start date: May 13, 2023
• Est. completion date: May 13, 2024

Study information

• Verified date: July 2023
• Source: Methodist Health System
• Contact: Colette Ngo Ndjom, MS
• Phone: 214-947-1281
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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].

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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatorenal Syndrome
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Liver Institute of Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome for HRS-AKI patients	Mortality rates, morbidities, complications, and other clinically relevant outcomes in HRS-AKI patients	4 years
Secondary	post transplant mortality rates	post-transplant mortality rates HRS-AKI-associated costs	4 years