A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 3

Conditions: Bladder Cancer

Treatments: Other: standard fluid management; Other: fluid management guided by the EV1000

Study type: Interventional

Funder types: Other

Identifiers

NCT02145871

14-069

Details and patient eligibility

About

The purpose of this study is to help us learn what is the best amount of fluid to give to patients during bladder surgery in order to avoid delayed bowel function after surgery, which could prolong hospital stay.

Enrollment: 282 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (21 years old or greater) who are able to provide informed consent
• Patients who undergo an open, elective radical cystectomy

Exclusion criteria

• Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
• Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery)
• Presence of ascites, because increased abdominal pressure interferes with EV1000 reading accuracy
• BMI > 45 or <17, because increased abdominal pressure interferes with EV1000 reading accuracy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

Standard fluid management

Active Comparator group

Description:

The non-intervention group will receive maintenance crystalloid fluid at 10cc/kg/h. Blood loss will be replaced 1:1 with albumin. Transfusion will follow transfusion criteria. Fluid management will not be dependent on the EV1000

Treatment:

Other: standard fluid management

Goal directed fluid therapy (GDT)

Experimental group

Description:

In the GDT arm, patient's SV will be optimized before induction with crystalloid boluses prior to induction of general anesthesia. The GDT arm will have fluid therapy guided by the Edwards EV1000-clinical platform and maintenance crystalloid fluid will be 3cc/kg/h. During the surgical procedure when SVV rises above 12 an albumin bolus will be administered at 250 ml increments until the SVV falls below 8. Transfusion will follow transfusion criteria.

Treatment:

Other: fluid management guided by the EV1000