Clinical Trial: Prediction of Fluid Responsiveness in Children With Single Ventricle
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-Induced Change of Blood Pressure in Children With Bidirectional Cavopulmonary Shunt or Fontan Pathway
Brief Summary: The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).
Detailed Summary:
The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).
When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.
To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration.
Finally, patients will be divided into fluid responder group and non-responder group. If cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. Using ROC curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated
Sponsor: Seoul National University Hospital
Current Primary Outcome: Changes in stroke volume index after volume expansion [ Time Frame: before and after fluid administration (20 min) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Changes in pleth variability index after volume expansion [ Time Frame: before and after fluid administration (20 min) ]
- 3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion [ Time Frame: before and after fluid administration (20 min) ]
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: July 5, 2016
Date Started: August 2016
Date Completion: September 2018
Last Updated: July 5, 2016
Last Verified: July 2016
