Cirrhosis, LiverNCT06174272
Transitional Care Program for Fluid Overload in Cirrhosis
A study testing Transitional Care Program in people with Cirrhosis, Liver, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Transitional Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Placement of a TIPS.
- Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Alison J Faust, MD, 7175311017, afaust1@pennstatehealth.psu.edu
About this study
Official title: Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study
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:
Read more
- 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
- Being tested
- Transitional Care Program
- Keywords
- ascites, anasarca, edema
- Medical subject headings
- Liver Cirrhosis, Ascites, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Care ProgramBehavioural
Intensive monitoring post discharge for cirrhosis and fluid overload
| Study group | Role | What they receive |
|---|---|---|
| Transitional Care Program | Experimental | 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. Receives: Behavioral: Transitional Care Program |
| Standard of Care | No intervention | Participants will be given typical discharge and follow up instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of the program
how much time does it take to review material and complete phone calls
Measured: all 8 weeks of each participant
Number of instances of weight monitoring
at home monitoring weight
Measured: 8 weeks for each participant
Number of successful phone calls
weekly phone call with participant
Measured: 8 weeks for each participant
Number of follow up visits
lab visits, primary care visits, hepatology visits
Measured: 8 weeks for each participant
Secondary outcomes (4)
Number of Hospitalizations per participant
number of admissions to the hospital
Measured: 12 months
Number of subjects that develop Acute Kidney Injury
Creatinine increase of >0.3g/dL
Measured: 12 months
Number of subjects that continue to have volume overload
persistent weight above dry weight and/or ongoing ascites/lower extremity edema/pleural effusion
Measured: 12 months
Number of subjects that expire
subject death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start15 Feb 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Krok, Milton S. Hershey Medical Center
- Investigators
- Karen L Krok, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174272
- Sponsor's protocol ID
- STUDY00023071
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study
- ClinicalTrials.gov ID
- NCT06174272
- Acronym / sponsor ID
- STUDY00023071
- Conditions
- Cirrhosis, Liver
- Keywords
- ascites, anasarca, edema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transitional Care Program | Experimental | Behavioral: Transitional Care ProgramParticipants 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. |
| Standard of Care | No intervention | –Participants will be given typical discharge and follow up instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Placement of a TIPS.
- Ascites from an etiology other than cirrhosis, such as malignancy, heart failure, pancreatitis, nephrotic syndrome.
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitional Care ProgramIntensive monitoring post discharge for cirrhosis and fluid overload | Behavioural | Transitional Care Program |
Primary outcome
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
Number of instances of weight monitoring
Time frame: 8 weeks for each participant
at home monitoring weight
Number of successful phone calls
Time frame: 8 weeks for each participant
weekly phone call with participant
Number of follow up visits
Time frame: 8 weeks for each participant
lab visits, primary care visits, hepatology visits
4 secondary outcomes
Number of Hospitalizations per participant
Time frame: 12 months
Number of subjects that develop Acute Kidney Injury
Time frame: 12 months
Number of subjects that continue to have volume overload
Time frame: 12 months
Number of subjects that expire
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen L Krok, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Care Program in people with Cirrhosis, Liver, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen L Krok, MD (7175311017, kkrok@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of the program (time frame: all 8 weeks of each participant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.