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

July 7, 2019 updated by: Fatma Alzahraa Mohamed Ibrahim Hassan Haggag
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sixteen consecutive pediatric patients having end stage renal disease scheduled for living related donor renal transplant surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sixteen patients having end stage renal disease
Intravascular volume assessment in 16 pediatric patients under going renal transplant surgery using ultrasonography, CVP and echocardiography
Device: ultrasonography
Intravascular volume assessment using ultrasonography, CVP and echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal jugular vein diameter, cross sectional area and left ventricular end-diastolic area
Time Frame: 3months
Correlation of IJV diameter and cross sectional area to LVEDA.
3months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal jugular vein diameter, cross sectional area and central venous pressure
Time Frame: 3months
Correlation of IJV diameter and cross sectional area to CVP.
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatma Alzahraa Mohamed Ibrahim Hassan Haggag

Investigators

  • Study Director: Sherif Soaida, Departement of Anesthesia Kasr Alainy Medical School Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 7, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008@123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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