The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

Not Applicable

Completed

• Conditions: Radical Cystectomy; Bladder Cancer
• Interventions: Other: Goal-directed therapy

• Registration Number: NCT03505112
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-12
• Study Start: 2018-04-20
• Study First Posted: 2018-04-23
• Primary Completion: 2021-10-24
• Study Completion: 2021-10-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal-directed therapy group	Goal-directed therapy	The patients in goal-directed therapy (GDT) group will be managed according to the goal-directed therapy protocol during the surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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.

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Select, Korea, Republic of