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

Status

Completed

Conditions

Intervention / Treatment

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

      • Assiut, Egypt, 71717
        • Assiut University

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.

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.

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