Actively Recruiting
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy A Randomized Controlled Trial
Led by Johns Hopkins University · Updated on 2025-11-20
130
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with muscle-invasive bladder cancer who are undergoing radical cystectomy, a major surgery often linked to high rates of complications and hospital readmissions. This trial evaluates whether adding a home intravenous fluid (IVF) infusion program to an Enhanced Recovery After Surgery (ERAS) protocol can reduce 90-day hospital readmissions compared to ERAS alone. The study is a randomized controlled trial at a single institution aiming to provide clearer evidence on the benefits and risks of home IVF after surgery. Participants are randomly assigned to one of two groups: one group receives the ERAS protocol plus a home IVF program with 1 liter of fluid (lactated ringers or normal saline) given three times a week for four weeks via vascular access established before or after surgery; the other group receives the ERAS protocol alone without home IVF. Patients in the home IVF group may have vascular access from prior chemotherapy or receive a midline catheter placed post-operatively. Both groups receive home nursing care for wound and ostomy management and education. During the study, patients will have routine follow-up including phone calls at 30 and 90 days after surgery to assess complications, emergency visits, and hospital readmissions. Clinic visits for ostomy teaching and wound checks occur about 7 to 14 days after surgery. Researchers will measure the percentage of participants with hospital readmissions within 90 days as the primary outcome, along with secondary outcomes like 30-day readmissions, emergency department visits, and all-cause complications. The total study duration for each participant includes the four-week home care period and follow-up assessments.
CONDITIONS
Brief Title
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients greater than 18 years of age
- Confirmed urothelial carcinoma on pathology, including muscle invasive, non-muscle invasive, and variant histology
- Patient electing to undergo radical cystectomy with bilateral pelvic lymphadenectomy after counseling with a urologic oncologist
You will not qualify if you...
- Patients undergoing radical cystectomy for benign indications such as chronic bladder pain, fistulas, or severe lower urinary tract symptoms
- Patients undergoing radical cystectomy for a non-bladder primary malignancy such as rectal, colon, or uterine cancers
- Patients with extensive locally advanced disease requiring pelvic exenteration
- Contraindication to receiving home intravenous fluid therapy due to pre-existing cardiac, renal, or hepatic dysfunction
- Unwilling or unable to participate in 30 and 90 day follow-up phone calls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo radical cystectomy surgery followed by the Enhanced Recovery After Surgery (ERAS) protocol. Those in the home intravenous fluid (IVF) group will have vascular access established during post-operative hospitalization if not already present and receive home intravenous fluid infusions three times a week for four weeks with a home nurse. Participants not receiving home IVF will follow the ERAS protocol without home intravenous fluids but still receive home nursing for wound care, ostomy teaching, and hydration education.
Home nursing visits three times a week for 4 weeks; 1 to 2 clinic or local follow-up visits approximately 7 to 14 days after surgery
Duration - Up to 90 days post-surgery
Participants receive phone calls at 30 and 90 days post-operatively to assess for complications, emergency department visits, and hospital readmissions.
2 phone calls (at 30 and 90 days post-surgery)
Trial Site Locations
Total: 2 locations
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
T
Tyler S Garman, MD
M
Max R Kates, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here