Postoperative Complications
Conditions
Keywords
stroke volume variation, central venous pressure, serum lactate, serum creatinine
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.
Interventions
PROCEDUREFluid 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
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor
Intervention model description
Group SVV: fluid management guided by stroke volume variation (SVV) protocol Group CVP: fluid management guided by central venous pressure (CVP) protocol
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lactate and creatinine level | at the end of surgery up to 48 hours | serum lactate and creatinine level |
Countries
Thailand
Outcome results
None listed