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Transitional Care Program for Fluid Overload in Cirrhosis

ConditionCirrhosis, Liver
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Placement of a TIPS.

Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.

Non-English speaking

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transitional Care Program

    Behavioral

    Intensive monitoring post discharge for cirrhosis and fluid overload

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Transitional Care ProgramExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

feasibility of the program

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

Time frame
all 8 weeks of each participant
2

Number of instances of weight monitoring

at home monitoring weight

Time frame
8 weeks for each participant
3

Number of successful phone calls

weekly phone call with participant

Time frame
8 weeks for each participant
4

Number of follow up visits

lab visits, primary care visits, hepatology visits

Time frame
8 weeks for each participant

Secondary outcomes

1

Number of Hospitalizations per participant

number of admissions to the hospital

Time frame
12 months
2

Number of subjects that develop Acute Kidney Injury

Creatinine increase of \>0.3g/dL

Time frame
12 months
3

Number of subjects that continue to have volume overload

persistent weight above dry weight and/or ongoing ascites/lower extremity edema/pleural effusion

Time frame
12 months
4

Number of subjects that expire

subject death

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

Source ClinicalTrials.gov
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