ClinicalTrials.gg
RecruitingNCT06174272Updated Mar 9, 2026

Transitional Care Program for Fluid Overload in Cirrhosis

An interventional study of Transitional Care Program in Cirrhosis, Liver, sponsored by Milton S. Hershey Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cirrhosis, Liver

Keywords

  • ascites
  • anasarca
  • edema
03

In context

Liver Cirrhosis

1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.

This study's planned enrollment of 20 is below the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 492 studies on the registry; 60 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 46 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Placement of a TIPS.
  • Ascites from an etiology other than cirrhosis, such as , heart failure, pancreatitis, nephrotic syndrome.
  • Non-English speaking
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Transitional Care Program

  • No intervention
    Standard of Care

    Participants will be given typical discharge and follow up instructions.

Interventions

  • BehavioralTransitional Care Program

    Intensive monitoring post discharge for cirrhosis and fluid overload

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06174272
Responsible party
Karen Krok (Professor of Medicine, Milton S. Hershey Medical Center) — Principal investigator
First posted
Dec 18, 2023
Start date
Feb 15, 2025
Primary completion
Feb 15, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Mar 9, 2026

Study contacts

Karen L Krok, MD
Contact
kkrok@pennstatehealth.psu.edu
7175311017
Shannon F Dalessio
Contact
sdalessio@pennstatehealth.psu.edu
7175310003 ext. 320883
Karen L Krok, MD
principal investigator · Penn State College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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