Transitional Care Program for Fluid Overload in Cirrhosis

NCT ID: NCT06174272

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Transitional Care Program

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.

Group Type: EXPERIMENTAL

Transitional Care Program

Intervention Type: BEHAVIORAL

Intensive monitoring post discharge for cirrhosis and fluid overload

Standard of Care

Participants will be given typical discharge and follow up instructions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transitional Care Program

Intensive monitoring post discharge for cirrhosis and fluid overload

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Karen Krok

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen L Krok, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen L Krok, MD

Role: CONTACT

kkrok@pennstatehealth.psu.edu

7175311017

Shannon F Dalessio

Role: CONTACT

sdalessio@pennstatehealth.psu.edu

7175310003 ext. 320883

Facility Contacts

Alison J Faust, MD

Role: primary

afaust1@pennstatehealth.psu.edu

717-531-1017

Other Identifiers

STUDY00023071

Identifier Type: -

Identifier Source: org_study_id