Pulse Pressure Variation for Prediction of Fluid Responsiveness in Coronary Artery Disease Patients With Diastolic Dysfunction

NCT ID: NCT01819571

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-10-31

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.

Conditions

Fluid Responsiveness Predictability

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Normal diastolic function group

Group Type: EXPERIMENTAL

Fluid loading (Voluven)

Intervention Type: DRUG

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

Diastolic dysfunction group

Group Type: ACTIVE_COMPARATOR

Fluid loading (Voluven)

Intervention Type: DRUG

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

Interventions

Fluid loading (Voluven)

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

Intervention Type: DRUG

Other Intervention Names

Fluid loading

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of anesthesiology and pain medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

1-2011-0056

Identifier Type: -

Identifier Source: org_study_id