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Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes

NCT ID: NCT02373735

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to investigate the effect of stroke volume variation (SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.

Detailed Description

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The purpose of this study is to investigate the effect of stroke volume variation(SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy. Patients were randomized to fluid management to maintain \<10% SVV (group A), or to undergo fluid management during radical cystectomy to maintain SVV 10-20% (group B). Intraoperative blood loss and hemodynamic parameters, perioperative laboratory data, and postoperative complications were compared between two groups.

Conditions

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Bladder Cancer

Keywords

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stroke volume variation radical cystectomy blood loss postoperative complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A (SVV <10% group)

* infuse crystalloid (Hartmann's solution) 6-10 ml/kg/hr continuously during surgery
* infuse colloid (Volulyte) 200 ml if SVV is ≥ 10% during the surgery

Interventions: crystalloid (Hartmann's solution), colloid (Volulyte)

Group Type ACTIVE_COMPARATOR

crystalloid

Intervention Type OTHER

Group A (SVV \<10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy

colloid

Intervention Type OTHER

Group A (SVV \<10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is \> 20%

Group B (SVV 10-20% group)

* infuse crystalloid (Hartmann's solution) 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy
* infuse colloid (Volulyte) 200 ml if SVV is \> 20%
* infuse mannitol 0.5 g/kg or lasix 5 mg if SVV \< 10%

Interventions: crystalloid (Hartmann's solution), colloid (Volulyte), mannitol, lasix

Group Type EXPERIMENTAL

crystalloid

Intervention Type OTHER

Group A (SVV \<10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy

colloid

Intervention Type OTHER

Group A (SVV \<10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is \> 20%

mannitol

Intervention Type OTHER

Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is \< 10%

lasix

Intervention Type OTHER

Group B (SVV 10-20%): infuse lasix 5 mg if SVV is \< 10%

Interventions

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crystalloid

Group A (SVV \<10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy

Intervention Type OTHER

colloid

Group A (SVV \<10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is \> 20%

Intervention Type OTHER

mannitol

Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is \< 10%

Intervention Type OTHER

lasix

Group B (SVV 10-20%): infuse lasix 5 mg if SVV is \< 10%

Intervention Type OTHER

Other Intervention Names

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Hartmann's solution volulyte

Eligibility Criteria

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Inclusion Criteria

* Bladder cancer patients who received radical cystectomy
* Patients with American Society of Anesthesiologists physical status scale classification 1, 2
* Patients who agree with written informed consent

Exclusion Criteria

* Patients with history of arrhythmia, heart failure patients
* Patients with history of renal failure patients
* Patients with history of abdominal surgery
* Patients who received emergency operation
* Patients who do not agree with study
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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S2014-2192

Identifier Type: -

Identifier Source: org_study_id