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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Procedure: Fluid management protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40-80 years old Patient had aortic aneurysm both thoracic and abdominal types Scheduled for elective EVAR procedures New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III Body mass index (BMI) 18-24 kg/m2 Provided informed consent before surgery Exclusion Criteria: Scheduled for emergency or redo surgery Received prior fluid therapy (>2,500 ml/day over the 48 h before the surgery) Presence of congenital heart disease, cardiomyopathy, rheumatic heart disease, or significant arrhythmia or cardiopulmonary dysfunction, or significant renal or liver diseases Preoperative use of vasoactive drugs (e.g. digoxin, nitroglycerine, nifedipine) for ≥3 months Difficulty (or contraindication to) placing a central venous catheter Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation) Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group SVV: fluid management guided by stroke volume variation (SVV) protocol Group CVP: fluid management guided by central venous pressure (CVP) protocol
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVV group<br>Fluid management protocol | Procedure: Fluid management protocol<br>* 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<br>|
| Active Comparator: CVP group<br>Fluid management protocol | Procedure: Fluid management protocol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate and creatinine level | serum lactate and creatinine level | at the end of surgery up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke volume variation, central venous pressure, serum lactate, serum creatinine