Prediction of Fluid Responsiveness in Children With Single Ventricle

Hypovolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826135
• Other study ID #: H1603-156-752
• Status: Completed
• Phase: N/A
• Start date: December 2, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 30, 2021
• Est. primary completion date: June 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Procedure:
• abdominal compression
When there are clinical signs of hypovolemia, such as hypotension in pediatric patients with single ventricle, 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in stroke volume index after volume expansion		before and after fluid administration (20 min)
Secondary	Changes in pleth variability index after volume expansion		before and after fluid administration (20 min)
Secondary	3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion		before and after fluid administration (20 min)