NCT01819571

Brief Summary

The investigators hypothesized that predictability of pulse pressure variation (PPV) on fluid responsiveness would be reduced in patients with coronary disease who have diastolic dysfunction.

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 Jan 2012

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

January 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1.8 years

First QC Date

March 14, 2013

Last Update Submit

February 17, 2014

Conditions

Fluid Responsiveness Predictability

Keywords

pulse pressure variationfluid responsivenessdiastolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • predictability of pulse pressure variation (PPV) on fluid responsiveness in patients with coronary disease who have normal diastolic function and diastolic dysfunction.

    After induction of anesthesia and applying mechanical ventilation, hemodynamic parameters (including PPV measured by Philips IntelliVue MP 70®) were recorded

    10 minutes after fluid replacement

Study Arms (2)

Normal diastolic function group

EXPERIMENTAL
Drug: Fluid loading (Voluven)

Diastolic dysfunction group

ACTIVE COMPARATOR
Drug: Fluid loading (Voluven)

Interventions

Fluid loading (Voluven)DRUG

HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 8ml / kg loading during 15 minutes after induction of anesthesia on both groups

Also known as: Fluid loading
Diastolic dysfunction groupNormal diastolic function group

Eligibility Criteria

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

You may qualify if:

  • Patients older than 20 years
  • scheduled for elective coronary artery bypass grafting
  • normal diastolic function (E/E' \< 8) or diastolic dysfunction (E/E' \>15) according to preoperative Echocardiographic evaluation

You may not qualify if:

  • arrythmia,
  • reduced left ventricular function (ejection fraction \< 40%)
  • valvular heart disease requiring concomitant surgical correction
  • pulmonary hypertension (mean pulmonary arterial pressure ≥30 mm Hg)
  • peripheral arterial occlusive disease, pulmonary disease (asthma, chronic obstructive pulmonary disease, and lung resection)
  • end-stage renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesiology and pain medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

HES 130-0.4

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 27, 2013

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

KR(1)