- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06081608
Acute Kidney Injury Among Pediatric Cancer Patients At South Egypt Cancer Institute
October 7, 2023 updated by: Ahmed Mohamed Amir Fathy Riad, Assiut University
Cancer is the second most frequent cause of premature death in children.
The incidence of pediatric cancer varies by region and country, but it is generally considered rare with an estimated 300,000 new cases diagnosed worldwide.
Acute kidney injury in pediatric cancer patients refers to the sudden and often temporary loss of renal function, which can lead to a variety of complications if not treated correctly.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
- Primary: To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
Secondary:
- Incidence of Hospital-acquired and community-acquired AKI
- Asses the risk factors of the incidence of AKI
- To determine in-hospital outcome (time to in-hospital death, length of hospital stay, and time to kidney recovery) of AKI.
This is a prospective study that will be carried out in the Paediatric Oncology and Haematological Malignancies Department including patients diagnosed with malignant tumours and hospitalized from 1st April 2023 for one year duration.
Study Type
Observational
Enrollment (Estimated)
2
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
- Child
- Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
•Children of both sexes (aged from 1 month to 18 years at diagnosis)
Description
Inclusion Criteria:
• Children of both sexes (aged from 1 month to 18 years at diagnosis)
- Patients with either hematological malignancies or solid tumors admitted to the Paediatric Oncology and Haematological Malignancies Department
Exclusion Criteria:
- Children who had an unconfirmed cancer diagnosis.
- Children more than 18 years at diagnosis.
- Children with preexisting chronic kidney disease (CKD) that defined as the presence of structural or functional kidney damage that persist over minimum of three month
- The patient underwent hematopoietic stem cell transplantation. Patients with 1 s.Cr level.
- Patient underwent renal transplant.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the cumulative incidence of AKI using KDIGO criteria in pediatric patients with malignancy in South Egypt Cancer Institute (SECI)
Time Frame: from November 2023 till November 2024
|
from November 2023 till November 2024
|
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 (Estimated)
November 1, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
October 7, 2023
First Submitted That Met QC Criteria
October 7, 2023
First Posted (Actual)
October 13, 2023
Study Record Updates
Last Update Posted (Actual)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 7, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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