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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218540
• Other study ID #: HE591258
• Status: Completed
• Phase: N/A
• First received: July 10, 2017
• Last updated: August 15, 2017
• Start date: May 1, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2017
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• Fluid 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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. Review. — View Citation

Kothandan H, Haw Chieh GL, Khan SA, Karthekeyan RB, Sharad SS. Anesthetic considerations for endovascular abdominal aortic aneurysm repair. Ann Card Anaesth. 2016 Jan-Mar;19(1):132-41. doi: 10.4103/0971-9784.173029. Review. — View Citation

Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lactate and creatinine level	serum lactate and creatinine level	at the end of surgery up to 48 hours