NCT01404455

Brief Summary

The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

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, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

April 1, 2011

Last Update Submit

January 16, 2012

Conditions

Stroke Volume Variation

Outcome Measures

Primary Outcomes (1)

  • The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure

    30 min

Secondary Outcomes (1)

  • Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure

    30 min

Study Arms (2)

Normal pulse pressure

OTHER

pulse pressure \<60mmHg

Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading

Wide pulse pressure

OTHER

pulse pressure ≥60mmHg

Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading

Interventions

HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loadingOTHER

HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia

Normal pulse pressureWide pulse pressure

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age ≥ 20
  • \. elective off-pump coronary artery bypass graft

You may not qualify if:

  • \. arrhythmia
  • EF \<40%
  • valvular heart dz
  • pul HTN
  • PAOD
  • lung dz
  • NYHA IV
  • ESRD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 1, 2011

First Posted

July 28, 2011

Study Start

December 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

KR(1)