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NCT02145871CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 20 Mar 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
282 (actual)
First submitted
21 May 2014
Start date
21 May 2014
Primary completion date
14 Mar 2024
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT02145871

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 282
  • From 21 May 2014 to the primary completion date, 14 Mar 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia

Lab values

  • 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)

Other

  • 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

Who the study is looking for

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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center - Commack
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.