Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising
1 other identifier
interventional
44
1 country
1
Brief Summary
Dynamic indices of preload depending on the heart-lung interaction require sinus rhythm and cannot be applied to patients with atrial fibrillation. PEEP-induced increase in central venous pressure (CVP) was shown to be a valid predictor of fluid responsiveness after cardiac surgery in patients with sinus rhythm, and was speculated to be of value in patients with rhythm other than sinus. The aim of this study is to assess the predictability of PEEP-induced increase in CVP and passive leg raising (PLR)-induced changes in stroke volume index (SVI) on fluid responsiveness in patients with atrial fibrillation following valvular heart surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
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
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 1, 2015
March 1, 2015
2.6 years
August 19, 2014
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fluid responsiveness
1. ventilator peep setting was adjusted to 0cmH2O as baseline 2. Then peep was increased to 10cmH2O for 5 min. 3. We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min. 4. After that, 300 ml of hydroxyethyl starch 130/0.4 was infused in the supine position for 10-20 min and haemodynamic variables including SVI were assessed 5 min after completion of fluid challenge.
1hr after arriving at ICU
Study Arms (2)
peep induced CVP
EXPERIMENTALpassive leg raising(PLR)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age ≥20
- atrial fibrillation patients who underwent elective valvular heart surgery
You may not qualify if:
- age \< 20
- LV ejection fraction \< 40%
- any pulmonary disease
- end stage renal disease
- high intrabdominal pressure patient
- contraindication of passive leg raising
- deep vein thrombosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
August 19, 2014
First Posted
August 25, 2014
Study Start
March 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 1, 2015
Record last verified: 2015-03