Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06095440
Enrollment
500
Registered
2023-10-23
Start date
2023-05-13
Completion date
2027-05-13
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatorenal Syndrome

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 \[1\].

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 \[1\].

Interventions

OTHERHepatorenal 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.

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome for HRS-AKI patients4 yearsMortality rates, morbidities, complications, and other clinically relevant outcomes in HRS-AKI patients

Secondary

MeasureTime frameDescription
post transplant mortality rates4 yearspost-transplant mortality rates HRS-AKI-associated costs

Countries

United States

Contacts

CONTACTColette Ngo Ndjom, MS
MHSIRB@mhd.com214-947-1281
CONTACTLoretta W Bedell, MPH
mhsirb@mhd.com214-947-4680
PRINCIPAL_INVESTIGATORParvez Mantry, MD

Methodist Health System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026