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

NCT03218540 | Completed

• 1 other identifier: HE591258
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

stroke volume variation; central venous pressure; serum lactate; serum creatinine

Outcome Measures

Primary Outcomes (1)

• lactate and creatinine level

  serum lactate and creatinine level

  at the end of surgery up to 48 hours

Study Arms (2)

SVV group

EXPERIMENTAL

Fluid management protocol

Procedure: Fluid management protocol

CVP group

ACTIVE COMPARATOR

Fluid management protocol

Procedure: Fluid management protocol

Interventions

Fluid management protocol PROCEDURE

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

CVP group; SVV group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (3)

• 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.

  PMID: 23264068 BACKGROUND

• 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.

  PMID: 26750684 RESULT

• Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. doi: 10.1016/j.bpa.2005.10.007.

  PMID: 16850777 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thepakorn Sathitkarnmanee

  Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group SVV: fluid management guided by stroke volume variation (SVV) protocol Group CVP: fluid management guided by central venous pressure (CVP) protocol

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 14, 2017
• Study Start: May 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)