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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04008953
Other study ID # 2008@123
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2019
Est. completion date November 2019

Study information

Verified date July 2019
Source Cairo University
Contact Fatma Haggag
Phone +96653475736
Email m_shawki2004@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is designed for volume assessment in pediatrics during major surgery using non-invasive tools as ultrasonography without the need of invasive techniques avoiding its complications and as a guide for fluid therapy needed for maintaining adequate hemodynamics


Description:

Intravascular volume assessment during surgery is important for maintaining adequate hemodynamics. Methods approved for volume assessment include the use of echocardiography to measure left ventricular end diastolic area (LVEDA), central venous pressure (CVP) and pulmonary artery diastolic pressure (PAD). LVEDA is considered the good predictor for volume status assessment. CVP and PAD are invasive can potentially subject the patient to complications. Recently study performed an ultrasound assessment of the internal jugular vein (IJV) as a useful means of volume status assessment intraoperative under general anesthesia. In the pediatric population, only few studies are carried out to assess the use of ultrasound for intravascular volume assessment. This study will evaluate use of Ultrasonography of IJV in volume assessment in pediatrics will undergo renal transplant surgery and correlate IJV diameter, cross sectional area to CVP and LVEDA.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16
Est. completion date November 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria:

- Pediatric patients with end stage renal disease

- Weight between: 12 to 30 kg

Exclusion Criteria:

- Infection at the site of CVP or generalized infection.

- IJV thrombosis

Study Design


Intervention

Device:
ultrasonography
Intravascular volume assessment using ultrasonography, CVP and echocardiography

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fatma Alzahraa Mohamed Ibrahim Hassan Haggag

Outcome

Type Measure Description Time frame Safety issue
Primary Internal jugular vein diameter, cross sectional area and left ventricular end-diastolic area Correlation of IJV diameter and cross sectional area to LVEDA. 3months
Secondary Internal jugular vein diameter, cross sectional area and central venous pressure Correlation of IJV diameter and cross sectional area to CVP. 3months
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