Back to resultsStroke Volume Variation vs Central Venous Pressure Guidance Fluid Management in Endovascular Aortic Repair
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Fluid management protocol
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring stroke volume variation, central venous pressure, serum lactate, serum creatinine
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
Sites / Locations
- Faculty of Medicine, Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SVV group
CVP group
Arm Description
Fluid management protocol
Fluid management protocol
Outcomes
Primary Outcome Measures
lactate and creatinine level
serum lactate and creatinine level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03218540
Brief Title
Stroke Volume Variation vs Central Venous Pressure Guidance Fluid Management in Endovascular Aortic Repair
Official Title
Directed Fluid Therapy Based on Stroke Volume Variations Improves Fluid Management in Endovascular Aortic Repair for Aortic Aneurysm Patients: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
stroke volume variation, central venous pressure, serum lactate, serum creatinine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group SVV: fluid management guided by stroke volume variation (SVV) protocol Group CVP: fluid management guided by central venous pressure (CVP) protocol
Masking
ParticipantOutcomes Assessor
Masking Description
The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SVV group
Arm Type
Experimental
Arm Description
Fluid management protocol
Arm Title
CVP group
Arm Type
Active Comparator
Arm Description
Fluid management protocol
Intervention Type
Procedure
Intervention Name(s)
Fluid management protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
lactate and creatinine level
Description
serum lactate and creatinine level
Time Frame
at the end of surgery up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thepakorn Sathitkarnmanee
Organizational Affiliation
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23264068
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.
Results Reference
background
PubMed Identifier
26750684
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.
Results Reference
result
PubMed Identifier
16850777
Citation
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.
Results Reference
result
Learn more about this trial
Stroke Volume Variation vs Central Venous Pressure Guidance Fluid Management in Endovascular Aortic Repair
We'll reach out to this number within 24 hrs