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

Khon Kaen University

Status: Completed

Conditions: Postoperative Complications

Treatments: Procedure: Fluid management protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03218540

HE591258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

SVV group

Experimental group

Description:

Fluid management protocol

Treatment:

Procedure: Fluid management protocol

CVP group

Active Comparator group

Description:

Fluid management protocol

Treatment:

Procedure: Fluid management protocol