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Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children

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ClinicalTrials.gov Identifier: NCT02471534
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypovolemia Procedure: abdominal compression Not Applicable

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.

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study on Prediction of Fluid Responsiveness Using an Abdominal Compression-induced Change of Blood Pressure in Children
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Pediatric patients with hypovolemia
Right 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.
Procedure: abdominal compression
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.




Primary Outcome Measures :
  1. Changes in cardiac index after volume expansion [ Time Frame: before and after fluid administration (20 min) ]

Secondary Outcome Measures :
  1. Changes in pleth variability index after volume expansion [ Time Frame: before and after fluid administration (20 min) ]
  2. Changes in respiratory changes of peak aortic blood flow velocities after volume expansion [ Time Frame: before and after fluid administration (20 min) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471534


Locations
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Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD, PhD Seoul National University Hospital
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Responsible Party: Jin-Tae Kim, Associated professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02471534    
Other Study ID Numbers: H1411-061-6254
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes