Clinical trial NCT02826135: Prediction of Fluid Responsiveness in Children With Single Ventricle
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypovolemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 description: 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 or decreased central venous pressure, 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

Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery
* Patients with bidirectional cavopulmonary shunt or fontan tract

Exclusion Criteria:

* renal, hepatic and pulmonary disease
* preoperative infection: increased CPR, WBC over 10,000, and with fever
* genetic and hematologic disease
* ventricular dysfunction
* increased intracranial pressure

Primary outcomes:
measure: Changes in stroke volume index after volume expansion
timeFrame: before and after fluid administration (20 min)
Secondary outcomes:
measure: Changes in pleth variability index after volume expansion
timeFrame: before and after fluid administration (20 min)
measure: 3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion
timeFrame: before and after fluid administration (20 min)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: