Transitional Care Program for Fluid Overload in Cirrhosis

NCT06174272 | Recruiting

• 1 other identifier: STUDY00023071
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about an intensive monitoring plan (transitional care program) in patients with cirrhosis and excessive swelling that are going to be discharged from the hospital. The main question\[s\] it aims to answer are:

• How much time and what resources are needed to run such a program
• How well do patients follow up with the phone calls, bloodwork, and doctor appointments?
• Do the patients enrolled in the program have less need for hospitalization later, less kidney injury, better fluid control, and/or better survival compared to patients that are not in the program? Participants will
• Be given a digital scale and a binder with educational material and a log to monitor their weights after discharge from the hospital
• Receive a phone call from the study team within 72 hours of discharge and weekly
• Be given a follow up appointment with hepatology within 4 weeks of discharge Researchers will compare participants in this program to patients that receive normal care to see if there are differences in need for hospitalization later, kidney injury, fluid control, and/or survival.

Conditions

Cirrhosis, Liver

Keywords

ascites; anasarca; edema

Outcome Measures

Primary Outcomes (4)

• feasibility of the program

  how much time does it take to review material and complete phone calls

  all 8 weeks of each participant

• Number of instances of weight monitoring

  at home monitoring weight

  8 weeks for each participant

• Number of successful phone calls

  weekly phone call with participant

  8 weeks for each participant

• Number of follow up visits

  lab visits, primary care visits, hepatology visits

  8 weeks for each participant

Secondary Outcomes (4)

• Number of Hospitalizations per participant

  12 months

• Number of subjects that develop Acute Kidney Injury

  12 months

• Number of subjects that continue to have volume overload

  12 months

• Number of subjects that expire

  12 months

Study Arms (2)

Transitional Care Program

EXPERIMENTAL

Participants will receive a digital scale and monitoring log, educational material, a phone call within 72 hours of discharge and weekly for 8 weeks, and a follow up appointment with a hepatologist within 4 weeks of discharge.

Behavioral: Transitional Care Program

Standard of Care

NO INTERVENTION

Participants will be given typical discharge and follow up instructions.

Interventions

Transitional Care Program BEHAVIORAL

Intensive monitoring post discharge for cirrhosis and fluid overload

Transitional Care Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age.
• Inpatient at Penn State Health, Milton S. Hershey Medical Center.
• Diagnosis of cirrhosis.
• Hospitalized with fluid overload (ascites and/or significant anasarca/edema) requiring diuretic therapy.
• English speaking

You may not qualify if:

• Placement of a TIPS.
• Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.
• Non-English speaking

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Ascites; Edema

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Karen L Krok, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen L Krok, MD

CONTACT

7175311017; kkrok@pennstatehealth.psu.edu

Shannon F Dalessio

CONTACT

7175310003; sdalessio@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: February 15, 2025
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)