The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer; Radical Cystectomy
• Intervention / Treatment: Other: Goal-directed therapy

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Select
    • Seoul, Select, Korea, Republic of, 110-744
      • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goal-directed therapy group; 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; 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.; Other Names: GDT
No Intervention: Control group; The patients in control group will be managed according to standard perioperative care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305. Erratum In: JAMA. 2014 Oct 8;312(14):1473.
• Wuethrich PY, Burkhard FC, Thalmann GN, Stueber F, Studer UE. Restrictive deferred hydration combined with preemptive norepinephrine infusion during radical cystectomy reduces postoperative complications and hospitalization time: a randomized clinical trial. Anesthesiology. 2014 Feb;120(2):365-77. doi: 10.1097/ALN.0b013e3182a44440.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): October 24, 2021
• Study Completion (Actual): October 24, 2021

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Goal-directed therapy; stroke volume index
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 1712-125-909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No