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

March 31, 2015 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1hr after arriving at ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2011-0686

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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