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Status unknownNCT04008953Updated Jul 9, 2019

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

An observational study in Chronic Kidney Failure, sponsored by Fatma Alzahraa Mohamed Ibrahim Hassan Haggag. Status unknown. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by Fatma Alzahraa Mohamed Ibrahim Hassan Haggag · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16
Ages
3 Years to 12 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Kidney Failure

Keywords

  • volume assessment
03

In context

Kidney Failure, Chronic

2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.

This study's planned enrollment of 16 is below the median of 120 across 441 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

This is the only study on the registry with Fatma Alzahraa Mohamed Ibrahim Hassan Haggag as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pediatric patients with end stage renal disease
  • Weight between: 12 to 30 kg

Exclusion criteria

Exclusion Criteria:

  • Infection at the site of CVP or generalized infection.
  • IJV thrombosis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Deviceultrasonography

    Intravascular volume assessment using ultrasonography, CVP and echocardiography

06

What researchers measure

Primary outcomes

  1. Internal jugular vein diameter, cross sectional area and left ventricular end-diastolic area

    Correlation of IJV diameter and cross sectional area to LVEDA.

    Time frame: 3months

Secondary outcomes

  1. Internal jugular vein diameter, cross sectional area and central venous pressure

    Correlation of IJV diameter and cross sectional area to CVP.

    Time frame: 3months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04008953
Lead sponsor
Fatma Alzahraa Mohamed Ibrahim Hassan Haggag
Responsible party
Fatma Alzahraa Mohamed Ibrahim Hassan Haggag (assistant lecturer, Cairo University) — Sponsor-investigator
First posted
Jul 5, 2019
Start date
Jul 2019 (estimated)
Primary completion
Oct 2019 (estimated)
Completion
Nov 2019 (estimated)
Last update
Jul 9, 2019

Study contacts

Fatma Haggag
Contact
m_shawki2004@yahoo.com
+96653475736
Sherif Soaida
Contact
sherif_soaida@hotmail.com
+20-1223663504
Sherif Soaida
study director · Departement of Anesthesia Kasr Alainy Medical School Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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