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

Phase 3

Completed

• Conditions: Bladder Cancer
• Interventions: Other: standard fluid management; Other: fluid management guided by the EV1000

• Registration Number: NCT02145871
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-23
• Status Verified: 2024-03
• Primary Completion: 2024-03-14
• Study Completion: 2024-03-14
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard fluid management	standard fluid management	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
Goal directed fluid therapy (GDT)	fluid management guided by the EV1000	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.

Primary Outcome Measures

Name	Time	Method
incidence of postoperative ileus (POI)	3 years	POI will be defined as intolerance of oral intake by postoperative day 5, or the cessation of diet and/or placement of an NGT for clinical signs or symptoms associated with POI, including one or more of the following: nausea, emesis, abdominal bloating or distension, or excessive burping. Rate of ileus will be compared between the treatment groups using the chi-square test. A 95% confidence interval for the difference in ileus rate will also be reported.

Secondary Outcome Measures

Name	Time	Method
compare total volume of fluid	the first 72 hours	given intraoperatively and during the first 72 hrs postoperatively
complications	1 year post operatively	Overall rate of grade 2-5 1-year complications, and rate of grade 2-5 gastrointestinal, pulmonary, renal, hematologic and cardiac complications will also be compared using the chi-square test. Based rate of grade 2-5 gastrointestinal, pulmonary, renal, hematologic and cardiac complications will also be compared using the chi-square test.

Trial Locations

Locations (5)

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center @ Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States