Back to resultsPrediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
Primary Purpose
Valvular Heart Surgery
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
peep induced CVP
passive leg raising(PLR)
Sponsored by
About this trial
This is an interventional diagnostic trial for Valvular Heart Surgery focused on measuring fluid responsiveness, atrial fibrillation, passive leg raising, central venous pressure, valvular heart surgery
Eligibility Criteria
Inclusion Criteria:
- age ≥20
- atrial fibrillation patients who underwent elective valvular heart surgery
Exclusion Criteria:
- age < 20
- LV ejection fraction < 40%
- any pulmonary disease
- end stage renal disease
- high intrabdominal pressure patient
- contraindication of passive leg raising
- deep vein thrombosis
Sites / Locations
- Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
peep induced CVP
passive leg raising(PLR)
Arm Description
Outcomes
Primary Outcome Measures
fluid responsiveness
ventilator peep setting was adjusted to 0cmH2O as baseline
Then peep was increased to 10cmH2O for 5 min.
We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min.
After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02224378
Brief Title
Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. The aim of this study is to assess the predictability of PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Surgery
Keywords
fluid responsiveness, atrial fibrillation, passive leg raising, central venous pressure, valvular heart surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
peep induced CVP
Arm Type
Experimental
Arm Title
passive leg raising(PLR)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
peep induced CVP
Intervention Type
Procedure
Intervention Name(s)
passive leg raising(PLR)
Primary Outcome Measure Information:
Title
fluid responsiveness
Description
ventilator peep setting was adjusted to 0cmH2O as baseline
Then peep was increased to 10cmH2O for 5 min.
We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min.
After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge.
Time Frame
1hr after arriving at ICU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥20
atrial fibrillation patients who underwent elective valvular heart surgery
Exclusion Criteria:
age < 20
LV ejection fraction < 40%
any pulmonary disease
end stage renal disease
high intrabdominal pressure patient
contraindication of passive leg raising
deep vein thrombosis
Facility Information:
Facility Name
Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
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