Program to help patients with cirrhosis manage fluid overload after hospital discharge
Transitional Care Program vs Standard of Care in Cirrhosis With Volume Overload: A Pilot Study
This study tests a new program that helps patients with cirrhosis manage swelling from fluid overload after leaving the hospital to see if it can reduce hospital visits and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT06174272 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on a transitional care program designed for patients with cirrhosis who are experiencing excessive swelling due to fluid overload. Participants will receive a digital scale and educational materials to monitor their weight after leaving the hospital, along with regular follow-up phone calls and appointments with hepatology. The study aims to evaluate the effectiveness of this program in reducing hospital readmissions, kidney injury, and improving overall fluid management and survival rates compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults over 18 years old with a diagnosis of cirrhosis and fluid overload requiring diuretic therapy.
Not a fit: Patients who have ascites from causes other than cirrhosis or who are non-English speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the management of fluid overload in cirrhosis patients, leading to better health outcomes and reduced hospitalizations.
How similar studies have performed: While similar transitional care programs have shown promise in other conditions, this specific approach for cirrhosis and fluid overload is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hershey, Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Karen L Krok, MD — Penn State College of Medicine
- Study coordinator: Karen L Krok, MD
- Email: kkrok@pennstatehealth.psu.edu
- Phone: 7175311017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.