Recruiting

ERAS & IVF

Sponsor:

Johns Hopkins University

Code:

NCT07225205

Conditions

Bladder Cancer

Muscle Invasive Bladder Cancer (MIBC)

Muscle Invasive Bladder Cancer Urothelial Carcinoma

Cystectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intravenous fluids

ERAS

Study Details

Brief summary:

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.

Conditions

Bladder Cancer

Muscle Invasive Bladder Cancer (MIBC)

Muscle Invasive Bladder Cancer Urothelial Carcinoma

Cystectomy

Study ID

NCT07225205

Start date

Nov 1, 2025

Status verified date

Nov, 2025

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Tyler S Garman, MD

410-955-6100tgarman1@jhu.edu

Max R Kates, MD

410-614-0009Mkates@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Tyler S Garman, MD

813-955-6100tgarman1@jh.edu

Max R Kates, MD

4105028130Mkates@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

  • Cystectomy
  • Bladder Cancer
  • Muscle Invasive Bladder Cancer (MIBC)
  • Fluids
  • IVF
  • ERAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-20.