Pulse Pressure Variation (PPV) to Predict Fluid Responsiveness During Cardiac Displacement in Patients Undergoing Off-pump Coronary Artery Bypass Surgery (OPCAB)

Ischemic Heart Disease Clinical Trial

Official title:

Pulse Pressure Variation to Predict Fluid Responsiveness During Cardiac Displacement in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041742
• Other study ID #: H-0910-047-297
• Status: Completed
• Phase: N/A
• First received: December 30, 2009
• Last updated: July 25, 2010
• Start date: December 2009
• Est. completion date: January 2010

Study information

• Verified date: July 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• fluid loading
fluid loading will be performed by using 6% hydroxyethyl starch solution , at 10 mL/kg.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse pressure variation		during displacement of the heart in OPCAB	No