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Completed

NCT Number: NCT02826135

Prediction of Fluid Responsiveness in Children With Single Ventricle

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).

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Key information

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abdominal compression

Procedure

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.

Primary outcomes

  1. Changes in stroke volume index after volume expansion

    Time frame: before and after fluid administration (20 min)

Secondary outcomes

  1. Changes in pleth variability index after volume expansion

    Time frame: before and after fluid administration (20 min)

  2. 3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion

    Time frame: before and after fluid administration (20 min)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2016
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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