Skip to main content
OpenTrials
Completed

NCT Number: NCT03505112

The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Radical Cystectomy Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, Select, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Goal-Directed Therapy

Other

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

Primary outcomes

  1. 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

  1. The incidence of postoperative gastrointestinal complications

    Time frame: 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.

  2. The incidence of postoperative complications of infections

    Time frame: 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.

  3. The incidence of postoperative wound complications

    Time frame: 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.

  4. The incidence of postoperative cardiac events

    Time frame: 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.

  5. The incidence of postoperative thromboembolic complications

    Time frame: 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.

  6. The incidence of postoperative genitourinary complications

    Time frame: 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.

  7. The incidence of postoperative neurological complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2018
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.