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

Not Applicable

Completed

• Conditions: Postoperative Complications
• Interventions: Procedure: Fluid management protocol

• Registration Number: NCT03218540
• Lead Sponsor: Khon Kaen University

Brief 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.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-14
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 40-80 years old
2. Patient had aortic aneurysm both thoracic and abdominal types
3. Scheduled for elective EVAR procedures
4. New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
5. Body mass index (BMI) 18-24 kg/m2
6. Provided informed consent before surgery

Exclusion Criteria

1. Scheduled for emergency or redo surgery
2. Received prior fluid therapy (>2,500 ml/day over the 48 h before the surgery)
3. Presence of congenital heart disease, cardiomyopathy, rheumatic heart disease, or significant arrhythmia or cardiopulmonary dysfunction, or significant renal or liver diseases
4. Preoperative use of vasoactive drugs (e.g. digoxin, nitroglycerine, nifedipine) for ≥3 months
5. Difficulty (or contraindication to) placing a central venous catheter
6. Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
7. Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVP group	Fluid management protocol	Fluid management protocol
SVV group	Fluid management protocol	Fluid management protocol

Primary Outcome Measures

Name	Time	Method
lactate and creatinine level	at the end of surgery up to 48 hours	serum lactate and creatinine level

Trial Locations

Locations (1)

Faculty of Medicine, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand