Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study

Chronic Kidney Failure Clinical Trial

Official title:

Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04008953
• Other study ID #: 2008@123
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

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