NCT03218540

Stroke Volume Variation vs Central Venous Pressure Guidance Fluid Management in Endovascular Aortic Repair

Directed Fluid Therapy Based on Stroke Volume Variations Improves Fluid Management in Endovascular Aortic Repair for Aortic Aneurysm Patients: a Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central venous pressure (CVP), guidance results in better clinical outcomes. Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine level. Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP guidance. Outcome analyses: Compare serum lactate, creatinine as well as other postoperative complications between both groups.

Detailed description

Objective: To compare postoperative clinical outcome in adult patient undergoing EVAR. Primary outcome: Postoperative serum lactate and creatinine. Secondary outcome: Postoperative complications. Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid management protocol. SVV group will be managed according to stroke volume variation (SVV) protocol, i.e., control SVV 10-13% and give fluid when SVV \> 13%. CVP group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP \< 8 mmHg. Outcome analyses: Postoperative serum lactate and creatinine of both groups will be compared using unpaired Student-t test. Secondary outcomes will be compared using chi-square test.

Conditions

• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Fluid management protocol	SVV protocol: keep SVV 10-13% and give fluid when SVV \> 13% CVP protocol: keep CVP 8-12 mmHG and give fluid when CVP \< 8 mmHg

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2017-07-14
• Last updated: 2017-08-18

Locations

1 site across 1 country: Thailand