The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Seoul National University Hospital
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- A composite of postoperative complications
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Goal-directed therapy (GDT) has been applied to various clinical settings and has been widely researched recently as a method for perioperative management of patients. Radical cystectomy is a complex surgical procedure in which the bladder is removed, followed by urinary diversion. It is an extensive and time-consuming intervention and has high probability of fluid imbalance and bleeding during surgery. We hypothesized that the application of GDT in these patients would improve clinical postoperative outcomes. Therefore, we will attempt to evaluate improvement of postoperative outcomes after applying GDT protocol based on changes in stroke volume index, cardiac index and mean arterial pressure in radical cystectomy.
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing open radical cystectomy
- •Patients with American Society of Anesthesiologists physical status I-III
Exclusion Criteria
- •Significant hepatic dysfunction, significant renal dysfunction (estimated glomerular filtration rate \<60 ml/min)
- •Congestive heart failure (New York Heart Association scores ≥3), Left Ventricular Ejection Fraction \< 35%
- •Arrhythmia
- •Coagulopathy (PT INR \>1.5)
Outcomes
Primary Outcomes
A composite of postoperative complications
Time Frame: through the hospitalization period, an average of 2 weeks
Total incidence of postoperative complications including gastrointestinal complications, complications of infections, wound complications, cardiac events, thromboembolic complications, genitourinary complications, neurological complications based on the Clavien-Dindo classification for radical cystectomy.
Secondary Outcomes
- The incidence of postoperative neurological complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative genitourinary complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative wound complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative gastrointestinal complications(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative complications of infections(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative cardiac events(through the hospitalization period, an average of 2 weeks)
- The incidence of postoperative thromboembolic complications(through the hospitalization period, an average of 2 weeks)