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

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ClinicalTrials.gov Identifier: NCT04008953
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Fatma Alzahraa Mohamed Ibrahim Hassan Haggag, Cairo University

Brief 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

Condition or disease Intervention/treatment
Chronic Kidney Failure Device: ultrasonography

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.

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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Internal jugular vein diameter, cross sectional area and central venous pressure [ Time Frame: 3months ]
    Correlation of IJV diameter and cross sectional area to CVP.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008953


Contacts
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Contact: Fatma Haggag +96653475736 m_shawki2004@yahoo.com
Contact: Sherif Soaida +20-1223663504 sherif_soaida@hotmail.com

Sponsors and Collaborators
Fatma Alzahraa Mohamed Ibrahim Hassan Haggag
Investigators
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Study Director: Sherif Soaida Departement of Anesthesia Kasr Alainy Medical School Cairo University

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Responsible Party: Fatma Alzahraa Mohamed Ibrahim Hassan Haggag, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04008953     History of Changes
Other Study ID Numbers: 2008@123
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fatma Alzahraa Mohamed Ibrahim Hassan Haggag, Cairo University:
volume assessment

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic