Chronic Kidney FailureNCT04008953
Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study
An observational study of Chronic Kidney Failure, run by Fatma Alzahraa Mohamed Ibrahim Hassan Haggag.
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 Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Sixteen consecutive pediatric patients having end stage renal disease scheduled for living related donor renal transplant surgery
Who may be able to join
- Pediatric patients with end stage renal disease
- Weight between: 12 to 30 kg
Who cannot join
- Infection at the site of CVP or generalized infection.
- IJV thrombosis
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Chronic Kidney Failure
- Being tested
- ultrasonography
- Keywords
- volume assessment
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
Intravascular volume assessment using ultrasonography, CVP and echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Sixteen patients having end stage renal disease | Intravascular volume assessment in 16 pediatric patients under going renal transplant surgery using ultrasonography, CVP and echocardiography Receives: Device: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal jugular vein diameter, cross sectional area and left ventricular end-diastolic area
Correlation of IJV diameter and cross sectional area to LVEDA.
Measured: 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.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma Alzahraa Mohamed Ibrahim Hassan Haggag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Alzahraa Mohamed Ibrahim Hassan Haggag, Cairo University
- Investigators
- Sherif Soaida, Study director, Departement of Anesthesia Kasr Alainy Medical School Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008953
- Sponsor's protocol ID
- 2008@123
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04008953
- Acronym / sponsor ID
- 2008@123
- Conditions
- Chronic Kidney Failure
- Keywords
- volume assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Fatma Alzahraa Mohamed Ibrahim Hassan HaggagUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sixteen patients having end stage renal disease | – | Device: ultrasonographyIntravascular volume assessment in 16 pediatric patients under going renal transplant surgery using ultrasonography, CVP and echocardiography |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Sixteen consecutive pediatric patients having end stage renal disease scheduled for living related donor renal transplant surgery
Key inclusion criteria (2 listed)
- Pediatric patients with end stage renal disease
- Weight between: 12 to 30 kg
Key exclusion criteria (2 listed)
- Infection at the site of CVP or generalized infection.
- IJV thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyIntravascular volume assessment using ultrasonography, CVP and echocardiography | Device | Sixteen patients having end stage renal disease |
Primary outcome
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.
1 secondary outcome
Internal jugular vein diameter, cross sectional area and central venous pressure
Time frame: 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherif Soaida study director
Departement of Anesthesia Kasr Alainy Medical School Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Failure, run by Fatma Alzahraa Mohamed Ibrahim Hassan Haggag.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Haggag (+96653475736, m_shawki2004@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal jugular vein diameter, cross sectional area and left ventricular end-diastolic area (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.