The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

NCT03505112 | Completed

• 1 other identifier: 1712-125-909
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Radical Cystectomy

Keywords

Goal-directed therapy; stroke volume index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The incidence of postoperative gastrointestinal complications

  through the hospitalization period, an average of 2 weeks

• The incidence of postoperative complications of infections

  through the hospitalization period, an average of 2 weeks

• The incidence of postoperative wound complications

  through the hospitalization period, an average of 2 weeks

• The incidence of postoperative cardiac events

  through the hospitalization period, an average of 2 weeks

• The incidence of postoperative thromboembolic complications

  through the hospitalization period, an average of 2 weeks

Study Arms (2)

Goal-directed therapy group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The patients in control group will be managed according to standard perioperative care.

Interventions

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.

Also known as: GDT

Goal-directed therapy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing open radical cystectomy
• Patients with American Society of Anesthesiologists physical status I-III

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, Select, 110-744, South Korea

Location

Related Publications (3)

• 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.

  PMID: 23887199 BACKGROUND

• 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.

  PMID: 24842135 BACKGROUND

• Yoon HK, Hur M, Kim DH, Ku JH, Kim JT. The effect of goal-directed hemodynamic therapy on clinical outcomes in patients undergoing radical cystectomy: a randomized controlled trial. BMC Anesthesiol. 2023 Oct 9;23(1):339. doi: 10.1186/s12871-023-02285-9.

  PMID: 37814224 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, single-center, double-blind, parallel-group, randomized, controlled trial

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 23, 2018
• Study Start: April 20, 2018
• Primary Completion: October 24, 2021
• Study Completion: October 24, 2021
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

KR (1)