NCT01041742

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

Same day

First QC Date

December 30, 2009

Last Update Submit

July 25, 2010

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • pulse pressure variation

    during displacement of the heart in OPCAB

Study Arms (1)

OPCAB

EXPERIMENTAL
Procedure: fluid loading

Interventions

fluid loadingPROCEDURE

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
OPCAB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective off-pump coronary artery bypass surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 21924634DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Yunseok Jeon, MD

    Seoul National University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2009

First Posted

January 1, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

KR(1)