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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
crystalloid
colloid
mannitol
lasix
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring stroke volume variation, radical cystectomy, blood loss, postoperative complications

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (SVV <10% group)

Group B (SVV 10-20% group)

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Intraoperative blood loss

Secondary Outcome Measures

Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death)
Postoperative complications include cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death
Length of hospital stay/ICU stay

Full Information

First Posted
February 12, 2015
Last Updated
December 28, 2015
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02373735
Brief Title
Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes
Official Title
Effect of Stroke Volume Variation Guided Fluid Therapy on the Blood Loss and Postoperative Outcomes in Radical Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stroke volume variation, radical cystectomy, blood loss, postoperative complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (SVV <10% group)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group B (SVV 10-20% group)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
crystalloid
Other Intervention Name(s)
Hartmann's solution
Intervention Description
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
Intervention Name(s)
colloid
Other Intervention Name(s)
volulyte
Intervention Description
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
Intervention Name(s)
mannitol
Intervention Description
Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10%
Intervention Type
Other
Intervention Name(s)
lasix
Intervention Description
Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10%
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Time Frame
During operation
Secondary Outcome Measure Information:
Title
Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death)
Description
Postoperative complications include cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death
Time Frame
During 30 days after operation
Title
Length of hospital stay/ICU stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, M.D., Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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

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