Clinical trial · Interventional
A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
NCT02145871CI-TRIAL-00075243completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluid management guided by the EV1000 | Other | — | UNRESOLVED |
| standard fluid management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard fluid management
- 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
- interventionNames
- Other: standard fluid management
- type
- EXPERIMENTAL
- label
- Goal directed fluid therapy (GDT)
- 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.
- interventionNames
- Other: fluid management guided by the EV1000
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.