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CompletedNCT01041742Updated Jul 27, 2010

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

An interventional study of fluid loading in Ischemic Heart Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-07-27.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 35 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing elective off-pump coronary artery bypass surgery

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    OPCAB

    Procedure: fluid loading

Interventions

  • Procedurefluid loading

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

    Also known as: HES 130/0.4; Voluven; Fresenius Kabe, Stans, Switzerland

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What researchers measure

Primary outcomes

  1. pulse pressure variation

    Time frame: during displacement of the heart in OPCAB

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 21924634 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01041742
Lead sponsor
Seoul National University Hospital
First posted
Jan 1, 2010
Start date
Dec 2009
Primary completion
Dec 2009
Completion
Jan 2010
Last update
Jul 27, 2010

Study contacts

Yunseok Jeon, MD
study director · Seoul National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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