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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373735
• Other study ID #: S2014-2192
• Status: Completed
• Phase: N/A
• First received: February 12, 2015
• Last updated: December 28, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bladder Cancer
• Hemorrhage

Intervention

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
• 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%
• mannitol
Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10%
• lasix
Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10%

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss		During operation	No
Secondary	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	During 30 days after operation	No
Secondary	Length of hospital stay/ICU stay		participants will be followed for the duration of hospital stay, an expected average of 30 days	No