NCT07225205 · Johns Hopkins University
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
What this study is about
Radical cystectomy is the the usual treatment for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity. Many complications may be driven by dehydration and it is unclear if a home given through a vein (IV) fluid (IVF) infusion program post-operatively, which is an accepted standard practice, is beneficial.
View original scientific description
Radical cystectomy is the standard of care for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity. Many complications may be driven by dehydration and it is unclear if a home intravenous fluid (IVF) infusion program post-operatively, which is an accepted standard practice, is beneficial. This study is a single institution randomized controlled trial where patients who choose to undergo radical cystectomy for bladder cancer will be randomized to an Enhanced Recovery After Surgery (ERAS) protocol with a home IVF program, consisting of 1 liter (L) of crystalloid fluid three times per week for four weeks, or ERAS protocol alone. The primary outcome will be 90-day hospital re-admissions, with secondary outcomes including 30 and 90 day complications.
Interventions
OTHER
Intravenous fluids
At home, the patient receives a 1L bolus of either lactated ringers or normal saline three times a week for four weeks with the patient's home nurse.
OTHER
ERAS
Patients assigned to not receive home IVF will receive everything in the investigator's current ERAS protocol except the home intravenous fluid program. Patients without preexisting vascular access will not receive a midline catheter post-operatively, however the participant will still receive home care for skilled nursing who will provide wound care, ostomy teaching, and education about perioperative fluid management.
Primary outcome measures
Percentage of participants with 90-day Hospital Readmission
Time frame: From date of surgery up to 90-days postoperatively
The primary outcome will be 90-day hospital readmissions that are unplanned, including admissions for observation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patients greater than 18 years of age and older
- 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.
Exclusion criteria
- Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms)
- Patients undergoing radical cystectomy for a non-bladder primary malignancy (e.g. rectal, colon, uterine cancers).
- Patients with extensive locally advanced disease necessitating a pelvic exenteration
- Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction)
- Unwilling or unable to participate in 30 and 90 day follow-up phone calls.
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2025 · Source of record for eligibility and locations