Prediction of Fluid Responsiveness in Children With Single Ventricle

Seoul National University

Status: Completed

Conditions: Hypovolemia

Treatments: Procedure: abdominal compression

Study type: Interventional

Funder types: Other

Identifiers

NCT02826135

H1603-156-752

Details and patient eligibility

About

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).

Full 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

Enrollment: 64 patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Pediatric patients with hypovolemic state

Experimental group

Description:

Right upper abdominal compression is performed in patients with hypovolemic signs including hypotension, decreased urine output or decreased central venous pressure. Changes of blood pressure during abdominal compression is continuously recorded.

Treatment:

Procedure: abdominal compression