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

NCT ID: NCT01041742

Last Updated: 2010-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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OPCAB

Group Type EXPERIMENTAL

fluid loading

Intervention Type PROCEDURE

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

Interventions

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fluid loading

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

Intervention Type PROCEDURE

Other Intervention Names

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HES 130/0.4; Voluven; Fresenius Kabe, Stans, Switzerland

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Yunseok Jeon, MD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 21924634 (View on PubMed)

Other Identifiers

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H-0910-047-297

Identifier Type: -

Identifier Source: org_study_id

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