Back to resultsPulse Pressure Variation (PPV) to Predict Fluid Responsiveness During Cardiac Displacement in Patients Undergoing Off-pump Coronary Artery Bypass Surgery (OPCAB)
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fluid loading
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- patients undergoing elective off-pump coronary artery bypass surgery
Exclusion Criteria:
- unstable angina, preoperative arrhythmia, reduced ventricular function (ejection fraction < 40%), more than mild degree valvular heart disease, preoperative use of vasopressors or mechanical assist devices, intra-cardiac shunt, pulmonary artery hypertension, severe peripheral vascular obstructive disease, or esophageal pathology precluding the use of transesophageal echocardiography (TEE)
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPCAB
Arm Description
Outcomes
Primary Outcome Measures
pulse pressure variation
Secondary Outcome Measures
Full Information
NCT ID
NCT01041742
First Posted
December 30, 2009
Last Updated
July 25, 2010
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01041742
Brief Title
Pulse Pressure Variation (PPV) to Predict Fluid Responsiveness During Cardiac Displacement in Patients Undergoing Off-pump Coronary Artery Bypass Surgery (OPCAB)
Official Title
Pulse Pressure Variation to Predict Fluid Responsiveness During Cardiac Displacement in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pulse pressure variation (PPV) known as a dynamic preload index is increasingly being used for guide of fluid management under various clinical situations. We hypothesized that PPV could play a role as a predictor of fluid responsiveness during displacement of the heart in patients undergoing off-pump coronary artery bypass surgery (OPCAB).
Detailed Description
The aim of this study was to investigate the ability of PPV to predict fluid responsiveness during displacement of the heart in patients undergoing off-pump coronary artery bypass surgery. After anesthesia, we will measure mean arterial pressure, heart rate, central venous pressure, mean pulmonary artery pressure, pulmonary arterial occlusion pressure, mixed venous oxygen saturation, PPV and cardiac index in patients receiving elective OPCAB. All parameters will be recorded at 5 minutes after the left anterior descending artery anastomosis, immediately after the displacement of the heart for the left circumflex artery anastomosis, and 10 minutes after fluid loading with hydroxyethyl starch 6%(10 mL/kg). Patients whose cardiac index increased by >15% to fluid loading will be defined as responders. To test the abilities of central venous pressure, pulmonary artery occlusion pressure and PPV to predict fluid responsiveness during heart displacement, areas under the receiver operating characteristics curves of the responders will be calculated and compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OPCAB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
fluid loading
Other Intervention Name(s)
HES 130/0.4; Voluven; Fresenius Kabe, Stans, Switzerland
Intervention Description
fluid loading will be performed by using 6% hydroxyethyl starch solution , at 10 mL/kg.
Primary Outcome Measure Information:
Title
pulse pressure variation
Time Frame
during displacement of the heart in OPCAB
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing elective off-pump coronary artery bypass surgery
Exclusion Criteria:
unstable angina, preoperative arrhythmia, reduced ventricular function (ejection fraction < 40%), more than mild degree valvular heart disease, preoperative use of vasopressors or mechanical assist devices, intra-cardiac shunt, pulmonary artery hypertension, severe peripheral vascular obstructive disease, or esophageal pathology precluding the use of transesophageal echocardiography (TEE)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
21924634
Citation
Lee JH, Jeon Y, Bahk JH, Gil NS, Kim KB, Hong DM, Kim HJ. Pulse-pressure variation predicts fluid responsiveness during heart displacement for off-pump coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1056-62. doi: 10.1053/j.jvca.2011.07.013. Epub 2011 Sep 15.
Results Reference
derived
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Pulse Pressure Variation (PPV) to Predict Fluid Responsiveness During Cardiac Displacement in Patients Undergoing Off-pump Coronary Artery Bypass Surgery (OPCAB)
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