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NCT Number: NCT06174272

Transitional Care Program for Fluid Overload in Cirrhosis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Location contact

Alison J Faust, MD

CONTACT

[email protected]

7175311017

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transitional Care Program

Behavioral

Intensive monitoring post discharge for cirrhosis and fluid overload

Primary outcomes

  1. feasibility of the program

    Time frame: all 8 weeks of each participant

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

  2. Number of instances of weight monitoring

    Time frame: 8 weeks for each participant

    at home monitoring weight

  3. Number of successful phone calls

    Time frame: 8 weeks for each participant

    weekly phone call with participant

  4. Number of follow up visits

    Time frame: 8 weeks for each participant

    lab visits, primary care visits, hepatology visits

Secondary outcomes

  1. Number of Hospitalizations per participant

    Time frame: 12 months

    number of admissions to the hospital

  2. Number of subjects that develop Acute Kidney Injury

    Time frame: 12 months

    Creatinine increase of >0.3g/dL

  3. Number of subjects that continue to have volume overload

    Time frame: 12 months

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

  4. Number of subjects that expire

    Time frame: 12 months

    subject death

Study contacts

Contact information is provided by the study sponsor or research team.

Karen L Krok, MD

CONTACT

[email protected]

7175311017

Shannon F Dalessio

CONTACT

[email protected]

7175310003 ext. 320883

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2023
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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