Back to resultsGDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT
Primary Purpose
Spine Disease
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
goal directed fluid therapy
Controlled
Sponsored by
About this trial
This is an interventional treatment trial for Spine Disease
Eligibility Criteria
Inclusion Criteria:
- ASA 1-3
- elective surgery
- thoracic/lumbar spine surgery >= 3 levels and duration >= 3 hours
Exclusion Criteria:
- Cr >2 mg/dl or eGFR < 60 ml/min
- coronary artery disease, congestive heart failure or cardiac arrhythmia
- BMI >30 kg/m2
- hemodynamic unstable, preoperatively
- uncontrolled hypertension
- respiratory system compliance < 30 ml/cmH2O
Sites / Locations
- Faculty of Medicine Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
GDFT group
controlled group
Arm Description
The GDFT group will receive 400 ml of 12.5% carbohydrate drink after 6 pm until the bed time in the day before surgery and 200 ml in the morning of the surgery day. Acetate ringer solution will be start at 7:00. After induction PPV will be measure and fluid bolus 200 ml in 10 minutes will be given if PPV >13 before prone position. During the operation, the patient in GDFT group will receipt fluid therapy according to acceptable PPV
The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order.
Outcomes
Primary Outcome Measures
episode of intraoperative hypotension
Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP < 90 mmHg or MAP < 60 mmHg or decrease of SPB >= 25% from baseline for 5 minutes or need vasopressor) therapy
Secondary Outcome Measures
unit of blood transfusion
all unit of blood transfusion will be record intraoperative and postoperative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03164811
Brief Title
GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT
Official Title
Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GDFT group
Arm Type
Experimental
Arm Description
The GDFT group will receive 400 ml of 12.5% carbohydrate drink after 6 pm until the bed time in the day before surgery and 200 ml in the morning of the surgery day. Acetate ringer solution will be start at 7:00. After induction PPV will be measure and fluid bolus 200 ml in 10 minutes will be given if PPV >13 before prone position. During the operation, the patient in GDFT group will receipt fluid therapy according to acceptable PPV
Arm Title
controlled group
Arm Type
Other
Arm Description
The carbohydrate drink will not be given. Fluid, blood and blood product administration will be under attending anesthesiologist order.
Intervention Type
Procedure
Intervention Name(s)
goal directed fluid therapy
Intervention Description
pulse pressure variation will be used to as a goal to guide fluid administration in this group
Intervention Type
Other
Intervention Name(s)
Controlled
Intervention Description
standard fluid treatment by an anesthesiologist
Primary Outcome Measure Information:
Title
episode of intraoperative hypotension
Description
Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP < 90 mmHg or MAP < 60 mmHg or decrease of SPB >= 25% from baseline for 5 minutes or need vasopressor) therapy
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
unit of blood transfusion
Description
all unit of blood transfusion will be record intraoperative and postoperative
Time Frame
intraoperative and up to 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1-3
elective surgery
thoracic/lumbar spine surgery >= 3 levels and duration >= 3 hours
Exclusion Criteria:
Cr >2 mg/dl or eGFR < 60 ml/min
coronary artery disease, congestive heart failure or cardiac arrhythmia
BMI >30 kg/m2
hemodynamic unstable, preoperatively
uncontrolled hypertension
respiratory system compliance < 30 ml/cmH2O
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT
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