Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children
1 other identifier
interventional
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Shorter than P25 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
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 6, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 2, 2016
April 1, 2016
6 months
June 6, 2015
April 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in cardiac 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)
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 hypovolemia
EXPERIMENTALRight upper abdominal compression is performed in patients with hypovolemic signs including hypotension, decreased urine output and central venous pressure less than 5 mmHg. Changes of blood pressure during abdominal compression is continuously recorded.
Interventions
When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, 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
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
- intracardiac and extracardiac shunt
- single ventricle
- right heart dysfunction
- any intracardiac valve pathology
- 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 Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, MD, PhD
Seoul National University Hospital
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
June 6, 2015
First Posted
June 15, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 2, 2016
Record last verified: 2016-04