RECRUITING

A Retrospective Analysis of Outcomes in Patients with Hepatorenal Syndrome At Methodist Dallas Medical Center

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 \[1\].

Official Title

A Retrospective Analysis of Outcomes in Patients with Hepatorenal Syndrome At Methodist Dallas Medical Center

Quick Facts

Study Start:2023-05-13
Study Completion:2025-05-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06095440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. 1. Presence of cirrhosis, acute liver failure, or acute-on-chronic liver failure
  3. 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)
  4. 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)
  5. 4. Absence of shock
  6. 5. No current or recent treatment with nephrotoxic drugs
  7. 6. Absence of parenchymal renal disease
  8. 7. Suggestion of renal vasoconstriction based on FENa \<0.2%
  1. * 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

Study Contact

Colette Ngo Ndjom, MS
CONTACT
214-947-1281
MHSIRB@mhd.com
Loretta W Bedell, MPH
CONTACT
214-947-4680
mhsirb@mhd.com

Principal Investigator

Parvez Mantry, MD
PRINCIPAL_INVESTIGATOR
Methodist Health System

Study Locations (Sites)

Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, 75203
United States

Collaborators and Investigators

Sponsor: Methodist Health System

  • Parvez Mantry, MD, PRINCIPAL_INVESTIGATOR, Methodist Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-13
Study Completion Date2025-05-13

Study Record Updates

Study Start Date2023-05-13
Study Completion Date2025-05-13

Terms related to this study

Additional Relevant MeSH Terms

  • Hepatorenal Syndrome