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Clinical Trials/NCT02826135
NCT02826135
Completed
Not Applicable

Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-Induced Change of Blood Pressure in Children With Bidirectional Cavopulmonary Shunt or Fontan Pathway

Seoul National University Hospital1 site in 1 country64 target enrollmentDecember 2, 2016
ConditionsHypovolemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypovolemia
Sponsor
Seoul National University Hospital
Enrollment
64
Locations
1
Primary Endpoint
Changes in stroke volume index after volume expansion
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2, 2016
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

Associated professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Changes in stroke volume index after volume expansion

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

Secondary Outcomes

  • Changes in pleth variability index after volume expansion(before and after fluid administration (20 min))
  • 3.Changes in respiratory changes of peak aortic blood flow velocities after volume expansion(before and after fluid administration (20 min))

Study Sites (1)

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