NCT04008953

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

July 2, 2019

Last Update Submit

July 7, 2019

Conditions

Keywords

volume assessment

Outcome Measures

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.

    3months

Secondary Outcomes (1)

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

    3months

Study Arms (1)

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

Intravascular volume assessment using ultrasonography, CVP and echocardiography

Sixteen patients having end stage renal disease

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Sherif Soaida

    Departement of Anesthesia Kasr Alainy Medical School Cairo University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

July 1, 2019

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

July 9, 2019

Record last verified: 2019-07