The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

NCT ID: NCT03505112

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2021-10-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Goal-directed therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

GDT

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Tae Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jin-Tae Kim

Seoul, Select, South Korea

Countries

South Korea

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.

Reference Type: BACKGROUND

PMID: 23887199 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24842135 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37814224 (View on PubMed)

Other Identifiers

1712-125-909

Identifier Type: -

Identifier Source: org_study_id