The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial

Conditions
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Bladder Cancer, Radical Cystectomy

Intervention / Treatment
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* Other: Goal-directed therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-center, double-blind, parallel-group, randomized, controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal-directed therapy group<br>The patients in goal-directed therapy (GDT) group will be managed according to the goal-directed therapy protocol during the surgery. | Other: Goal-directed therapy<br>* 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.<br>* Other names: GDT;|
| No Intervention: Control group<br>The patients in control group will be managed according to standard perioperative care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of postoperative complications | 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. | through the hospitalization period, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative gastrointestinal complications | Gastrointestinal complications include ileus, constipation, gastric ulcer, anastomic bowel leak according to the Clavien-Dindo classification for radical cystectomy. | through the hospitalization period, an average of 2 weeks | 
| The incidence of postoperative complications of infections | Complications of infections include urinary tract infection, sepsis, pneumonia, wound infection according to the Clavien-Dindo classification for radical cystectomy. | through the hospitalization period, an average of 2 weeks | 
| The incidence of postoperative wound complications | Wound Complications mean wound dehiscence diagnosed clinically and requiring resuturing, according to the Clavien-Dindo classification for radical cystectomy. | through the hospitalization period, an average of 2 weeks | 
| The incidence of postoperative cardiac events | 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. | through the hospitalization period, an average of 2 weeks | 
| The incidence of postoperative thromboembolic complications | Thromboembolic complication means pulmonary embolism evidenced by spiral computerized tomography scanning according to the Clavien-Dindo classification for radical cystectomy. | through the hospitalization period, an average of 2 weeks | 
| The incidence of postoperative genitourinary complications | Genitourinary complications include renal dysfunction, renal failure, urinary leakage according to the Clavien-Dindo classification for radical cystectomy. | through the hospitalization period, an average of 2 weeks | 
| The incidence of postoperative neurological complications | Neurological complications mean presence of a de novo focal deficit, confusion/delirium according to the Clavien-Dindo classification for radical cystectomy. | through the hospitalization period, an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Goal-directed therapy, stroke volume index