- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572204
Management of Grades 3-5 Renal Trauma in Pediatrics
February 4, 2023 updated by: Ahmed Hamdan Gameel, Assiut University
Management of Grades 3-5 Renal Trauma in Pediatrics: A Prospective Case Series
comparing conservative management versus interventional management in hemodynamically stable paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed conservatively.
Study Overview
Study Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt, 71717
- Assiut University
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-
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
1 second to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
60 children (age group 0-18 years) will be added to my study divided into two groups regardless of sex
Description
Inclusion Criteria:
- Children ( age group 0-18) who are diagnosed to have renal tissue injury grade 3-5 by contrast CT
Exclusion Criteria:
- Age group more than 18 years
- Low grade renal trauma 1-2
- Patients who get explored due to extra urologic indication without proper urologic assessment
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Conservative group
|
|
|
interventional group
|
Minimal: Such as PCN insertion Endosopic: Such as DJ insertion Surgical: Repair, Partial or total nephrectomy Angioembolization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stabilization of haemodynamic status of the patient in the first 24-72 hours
Time Frame: 24 to 72 hours
|
24 to 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Resolution of perinephric collection during follow up Triphasic MSCT abdomen and pelvis
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
October 1, 2020
Primary Completion (ACTUAL)
September 30, 2022
Study Completion (ACTUAL)
October 30, 2022
Study Registration Dates
First Submitted
September 27, 2020
First Submitted That Met QC Criteria
September 27, 2020
First Posted (ACTUAL)
October 1, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 4, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Renal trauma management
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.