The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Control group
    • The patients in control group will be managed according to standard perioperative care.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin-Tae Kim, Professor – Seoul National University Hospital
  • Overall Contact(s)
    • Jin-Tae Kim, MD, PhD, 82-02-2072-2467, jintae73@gmail.com

References

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.

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.

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