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

Valvular Heart Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224378
• Other study ID #: 4-2011-0686
• Status: Completed
• Phase: N/A
• First received: August 19, 2014
• Last updated: March 31, 2015
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Valvular Heart Surgery

Intervention

Procedure:
• peep induced CVP

• passive leg raising(PLR)

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid responsiveness	ventilator peep setting was adjusted to 0cmH2O as baseline; Then peep was increased to 10cmH2O for 5 min.; We set peep to baseline 0cmH2O again, making patients to semirecumbent position following passive leg raising at 30 degree for 5 min.; 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	No