Transitional Care Program for Fluid Overload in Cirrhosis

Cirrhosis, Liver Clinical Trial

Official title:

Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174272
• Other study ID #: STUDY00023071
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Alison J Faust, MD
• Phone: 7175311017
• Email: afaust1[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Behavioral:
• Transitional Care Program
Intensive monitoring post discharge for cirrhosis and fluid overload

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of the program	how much time does it take to review material and complete phone calls	all 8 weeks of each participant
Primary	Number of instances of weight monitoring	at home monitoring weight	8 weeks for each participant
Primary	Number of successful phone calls	weekly phone call with participant	8 weeks for each participant
Primary	Number of follow up visits	lab visits, primary care visits, hepatology visits	8 weeks for each participant
Secondary	Number of Hospitalizations per participant	number of admissions to the hospital	12 months
Secondary	Number of subjects that develop Acute Kidney Injury	Creatinine increase of >0.3g/dL	12 months
Secondary	Number of subjects that continue to have volume overload	persistent weight above dry weight and/or ongoing ascites/lower extremity edema/pleural effusion	12 months
Secondary	Number of subjects that expire	subject death	12 months