Directed Fluid Therapy Based on Stroke Volume Variations Improves Fluid Management in Endovascular Aortic Repair for Aortic Aneurysm Patients: a Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Complications
- Sponsor
- Khon Kaen University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- lactate and creatinine level
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Thepakorn Sathitkarnmanee
Associate Professor
Khon Kaen University
Eligibility Criteria
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
Outcomes
Primary Outcomes
lactate and creatinine level
Time Frame: at the end of surgery up to 48 hours
serum lactate and creatinine level