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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02224378
First received: August 19, 2014
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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 Intervention
Valvular Heart Surgery
Procedure: peep induced CVP
Procedure: passive leg raising(PLR)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • fluid responsiveness [ Time Frame: 1hr after arriving at ICU ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: December 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peep induced CVP Procedure: peep induced CVP
Active Comparator: passive leg raising(PLR) Procedure: passive leg raising(PLR)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02224378

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02224378     History of Changes
Other Study ID Numbers: 4-2011-0686
Study First Received: August 19, 2014
Last Updated: August 21, 2014
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014