A Study Comparing Standard Fluid Management with a Device for Goal-Directed Fluid Management in Patients Undergoing Bladder Removal Surgery

Protocol
14-069
Full Title
A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
Phase
III
Disease Status
Newly Diagnosed & Relapsed/Refractory
Purpose

After surgery to remove the bladder (cystectomy), which is part of the treatment for many patients with bladder cancer, the patient’s bowels temporarily stop working. The amount of time it takes for the bowels to work again varies from patient to patient and is affected by several factors, including the amount of fluid the patient receives during and after the surgery. Delays in the return of bowel function can increase the amount of time the patient has to stay in the hospital after cystectomy.

Doctors are seeking the best way to give patients fluids during bladder surgery to help bowel function return as soon as possible. In this study, researchers are comparing standard fluid management with the use of a device (the “EV1000 Flo-trac system”) that provides the surgical team with a number they can use to determine how much fluid to give patients during surgery and in the recovery room. This latter approach is called “goal-directed fluid management.” The EV1000 is attached to the standard arterial line inserted into a patient’s wrist before surgery.

The EV1000 has already been used at Memorial Sloan Kettering to decide how much fluid to give patients during surgery, but this is the first time it will be used for bladder surgery. Patients in this study will be randomly assigned to receive standard fluid management (in which fluid is given during surgery based on the patient’s height, weight, and blood loss) or the EV1000 approach, and researchers will compare the return to bowel function between the two groups.

Eligibility

This study includes patients age 21 and older who will be undergoing cystectomy.

For more information about this study, please contact Dr. Vittoria Arslan-Carlon at 212-639-6840.

Disease(s)
Bladder Cancer
Locations
Related Diseases

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