Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07225205
Status
Recruiting
Apply to this trial

Conditions

  • Bladder Cancer
  • Cystectomy
  • Muscle Invasive Bladder Cancer (MIBC)
  • Muscle Invasive Bladder Cancer Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravenous fluids — OTHER
    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.
  • ERAS — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Nov 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Home IVF + ERAS
    Patients assigned to the home IVF arm will undergo the investigator's current ERAS pathway, which involves establishing vascular access that can be used for 4 weeks at home. Many patients have existing vascular access via a port which the participant receives for neoadjuvant chemotherapy. If the patient does not have existing access, the JHH Vascular Access Team (VAT) is engaged during the post-operative hospitalization to place a midline catheter, which is a type of peripheral vascular access that is adequate for 4 week durations and is less invasive than central catheters. Once the patient has vascular access, the home care coordinator and social worker are engaged to organize home nursing for wound care, ostomy teaching, and home IVF. At home, the patient receives a 1L bolus of either lactated ringers or normal saline three times a week for four weeks with the participant's home nurse.
  • No Intervention: ERAS Alone
    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 Measure

Percentage of participants with 90-day Hospital Readmission [ Time Frame: From date of surgery up to 90-days postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Tyler Garman, MD
[email protected]
410-955-6100
Max R Kates, MD
[email protected]
410-614-0009
Max R Kates, MD (PRINCIPAL_INVESTIGATOR)
Sunil H Patel, MD (SUB_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287
Tyler S Garman, MD
[email protected]
813-955-6100
Max R Kates, MD
[email protected]
4105028130

Find similar trials in Baltimore, MD

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Johns Hopkins Hospital· Baltimore, MD

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