Bladder Cancer, Radical Cystectomy
Conditions
Keywords
Goal-directed therapy, stroke volume index
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.
Interventions
The patients in GDT group will receive intravenous crystalloid fluid or vasopressor or inotropic agent according to the goal-directed therapy protocol utilizing FloTrac / EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA). After induction of anesthesia, the baseline stroke volume index (SVI) is measured and then 200-250 ml of crystalloid is administered over 5-10 minutes. If SVI increase by ≥10%, 200-250 ml of crystalloid is given repeatedly until the increase in SVI \<10%. If SVI does not increase by ≥10% and there is no decrease in mean arterial pressure (MAP), revaluate SVI every 10 minutes. Despite an increase in SVI of \<10% after fluid challenge, if a decrease in MAP is accompanied by cardiac index (CI) ≤ 2.5 L/min/m2, dobutamine is administered by continuous infusion. If there is a decrease in MAP but no decrease in CI, start low dose norepinephrine continuous infusion.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, single-center, double-blind, parallel-group, randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A composite of postoperative complications | 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
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative complications of infections | through the hospitalization period, an average of 2 weeks | Complications of infections include urinary tract infection, sepsis, pneumonia, wound infection according to the Clavien-Dindo classification for radical cystectomy. |
| The incidence of postoperative wound complications | through the hospitalization period, an average of 2 weeks | Wound Complications mean wound dehiscence diagnosed clinically and requiring resuturing, according to the Clavien-Dindo classification for radical cystectomy. |
| The incidence of postoperative cardiac events | through the hospitalization period, an average of 2 weeks | Cardiac events include myocardial infarction, arrhythmia, congestive heart failure, pulmonary edema and transient brain natriuretic peptide increase (serum brain natriuretic peptide values 100-500 pg/ml) according to the Clavien-Dindo classification for radical cystectomy. |
| The incidence of postoperative gastrointestinal complications | through the hospitalization period, an average of 2 weeks | Gastrointestinal complications include ileus, constipation, gastric ulcer, anastomic bowel leak according to the Clavien-Dindo classification for radical cystectomy. |
| The incidence of postoperative genitourinary complications | through the hospitalization period, an average of 2 weeks | Genitourinary complications include renal dysfunction, renal failure, urinary leakage according to the Clavien-Dindo classification for radical cystectomy. |
| The incidence of postoperative neurological complications | through the hospitalization period, an average of 2 weeks | Neurological complications mean presence of a de novo focal deficit, confusion/delirium according to the Clavien-Dindo classification for radical cystectomy. |
| The incidence of postoperative thromboembolic complications | through the hospitalization period, an average of 2 weeks | Thromboembolic complication means pulmonary embolism evidenced by spiral computerized tomography scanning according to the Clavien-Dindo classification for radical cystectomy. |
Countries
South Korea
Outcome results
None listed