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

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Other: crystalloid; Other: colloid; Other: mannitol; Other: lasix

• Registration Number: NCT02373735
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-22
• Study First Posted: 2015-02-27
• Study Start: 2015-03
• Primary Completion: 2015-11
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (SVV <10% group)	colloid	* 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 B (SVV 10-20% group)	mannitol	* 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 B (SVV 10-20% group)	lasix	* 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 A (SVV <10% group)	crystalloid	* 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 B (SVV 10-20% group)	colloid	* 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 B (SVV 10-20% group)	crystalloid	* 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

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	During operation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of