Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373735
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Young-Kug Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Other: crystalloid Other: colloid Other: mannitol Other: lasix Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Stroke Volume Variation Guided Fluid Therapy on the Blood Loss and Postoperative Outcomes in Radical Cystectomy
Study Start Date : March 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Mannitol

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 Name: 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 Name: 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 Name: 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 Name: 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%




Primary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: During operation ]

Secondary Outcome Measures :
  1. 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

  2. Length of hospital stay/ICU stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373735


Locations
Layout table for location information
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Young-Kug Kim, M.D., Ph.D Asan Medical Center
Layout table for additonal information
Responsible Party: Young-Kug Kim, professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02373735    
Other Study ID Numbers: S2014-2192
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015
Keywords provided by Young-Kug Kim, Asan Medical Center:
stroke volume variation
radical cystectomy
blood loss
postoperative complications
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Pathologic Processes
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs