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

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471534
• Other study ID #: H1411-061-6254
• Status: Completed
• Phase: N/A
• First received: June 6, 2015
• Last updated: April 28, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypovolemia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cardiac index after volume expansion		before and after fluid administration (20 min)	No
Secondary	Changes in pleth variability index after volume expansion		before and after fluid administration (20 min)	No
Secondary	Changes in respiratory changes of peak aortic blood flow velocities after volume expansion		before and after fluid administration (20 min)	No