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

December 28, 2015 updated by: Young-Kug Kim, Asan Medical Center

Effect of Stroke Volume Variation Guided Fluid Therapy on the Blood Loss and Postoperative Outcomes in Radical Cystectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Other: 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
Other Names:
  • Hartmann's solution
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%
Other Names:
  • volulyte
Experimental: 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
Other: 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
Other Names:
  • Hartmann's solution
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%
Other Names:
  • volulyte
Other: mannitol
Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10%
Other: lasix
Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative blood loss
Time Frame: During operation
During operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death)
Time Frame: During 30 days after operation
Postoperative complications include cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death
During 30 days after operation
Length of hospital stay/ICU stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 30 days
participants will be followed for the duration of hospital stay, an expected average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Young-Kug Kim, M.D., Ph.D, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 22, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2014-2192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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