Prediction of Fluid Responsiveness in Atrial Fibrillation Patients Who Underwent Valvular Heart Surgery: Peep-induced Increase in Central Venous Pressure vs. Passive Leg Raising

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02224378
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : April 1, 2015
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Valvular Heart Surgery Procedure: peep induced CVP Procedure: passive leg raising(PLR) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: peep induced CVP Procedure: peep induced CVP
Active Comparator: passive leg raising(PLR) Procedure: passive leg raising(PLR)

Primary Outcome Measures :
  1. fluid responsiveness [ Time Frame: 1hr after arriving at ICU ]
    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.

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. age ≥20
  2. atrial fibrillation patients who underwent elective valvular heart surgery

Exclusion Criteria:

  1. age < 20
  2. LV ejection fraction < 40%
  3. any pulmonary disease
  4. end stage renal disease
  5. high intrabdominal pressure patient
  6. contraindication of passive leg raising
  7. deep vein thrombosis

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02224378

Korea, Republic of
Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT02224378     History of Changes
Other Study ID Numbers: 4-2011-0686
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Yonsei University:
fluid responsiveness
atrial fibrillation
passive leg raising
central venous pressure
valvular heart surgery

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes