Prediction of Fluid Responsiveness in Children With Single Ventricle
Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-Induced Change of Blood Pressure in Children With Bidirectional Cavopulmonary Shunt or Fontan Pathway
1 other identifier
interventional
64
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedStudy Start
First participant enrolled
December 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJuly 22, 2021
July 1, 2021
4.6 years
July 5, 2016
July 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in stroke volume index after volume expansion
before and after fluid administration (20 min)
Secondary Outcomes (2)
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 Arms (1)
Pediatric patients with hypovolemic state
EXPERIMENTALRight 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated professor
Study Record Dates
First Submitted
July 5, 2016
First Posted
July 7, 2016
Study Start
December 2, 2016
Primary Completion
June 20, 2021
Study Completion
June 30, 2021
Last Updated
July 22, 2021
Record last verified: 2021-07