Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT01819571 |
Date of registration:
|
14/03/2013 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Pulse Pressure Variation for Prediction of Fluid Responsiveness in Coronary Artery Disease Patients With Diastolic Dysfunction
|
Scientific title:
|
|
Date of first enrolment:
|
January 2012 |
Target sample size:
|
66 |
Recruitment status: |
Completed |
URL:
|
http://clinicaltrials.gov/show/NCT01819571 |
Study type:
|
Interventional |
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Korea, Republic of
| | | | | | | |
Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Fluid Responsiveness Predictability
|
Intervention(s)
|
Drug: Fluid loading (Voluven)
|
Primary Outcome(s)
|
predictability of pulse pressure variation (PPV) on fluid responsiveness in patients with coronary disease who have normal diastolic function and diastolic dysfunction.
[Time Frame: 10 minutes after fluid replacement]
|
Secondary ID(s)
|
1-2011-0056
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|