Cirrhosis, Liver
Conditions
Keywords
ascites, anasarca, edema
Brief 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.
Interventions
BEHAVIORALTransitional Care Program
Intensive monitoring post discharge for cirrhosis and fluid overload
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of the program | 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 | 8 weeks for each participant | at home monitoring weight |
| Number of successful phone calls | 8 weeks for each participant | weekly phone call with participant |
| Number of follow up visits | 8 weeks for each participant | lab visits, primary care visits, hepatology visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospitalizations per participant | 12 months | number of admissions to the hospital |
| Number of subjects that develop Acute Kidney Injury | 12 months | Creatinine increase of \>0.3g/dL |
| Number of subjects that continue to have volume overload | 12 months | persistent weight above dry weight and/or ongoing ascites/lower extremity edema/pleural effusion |
| Number of subjects that expire | 12 months | subject death |
Countries
United States
Contacts
CONTACTKaren L Krok, MD
CONTACTShannon F Dalessio
PRINCIPAL_INVESTIGATORKaren L Krok, MD
Penn State College of Medicine
Outcome results
None listed