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

Postoperative Complications Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Postoperative Complications

• NCT number: NCT03218540
• Study type: Interventional
• Source: Khon Kaen University
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Completion date: July 31, 2017