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

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT06095440
Collaborator
(none)
500
1
12
41.6

Study Details

Study Description

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].

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Analysis of Outcomes in Patients With Hepatorenal Syndrome at Methodist Dallas Medical Center
Actual Study Start Date :
May 13, 2023
Anticipated Primary Completion Date :
May 13, 2024
Anticipated Study Completion Date :
May 13, 2024

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome for HRS-AKI patients [4 years]

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

Secondary Outcome Measures

  1. post transplant mortality rates [4 years]

    post-transplant mortality rates HRS-AKI-associated costs

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liver Institute of Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT06095440
Other Study ID Numbers:
  • 020.HEP.2023.D
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023