- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06108765
Acute Kidney Injury in Poly Trauma Patients
October 25, 2023 updated by: Omar ibrahim abd elsalam, Assiut University
The aim of this study is to identify the incidence and the factors associated with acute kidney injury in adult poly trauma patients
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Trauma causes significant morbidity and mortality in all age groups but particularly for those below 60 years and is one of the top 5 causes of death (1,2).Most deaths occur in adults who are between 15 and 44 years(3).Polytrauma originates from the Greek words poly which means multiple and trauma which means wounds.
The term polytrauma, which was defined using the new Berlin definition, as cases with an Abbreviated Injury Scale (AIS)≥3 for two or more different body regions and one or more additional variables from five physiologic parameters (hypotension[systolic blood pressure≤90 mmHg], unconsciousness[Glasgow Coma Scale score≤8], acidosis [base excess≤ -6.0], coagulopathy [partial thromboplastin time≥40 s or international normalized ratio≥1.4],
and age [≥70 years]) [4].There are complex pathophysiological changes that happen in a polyrauma patient which requires effective treatment for improving morbidity and mortality outcomes.
Hemorrhage, systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are some of the complications of trauma whose effects are not only local but also systemic.
There are mechanisms and triggers which result in cardio-vascular shock, hemostasis, apoptosis, organ dysfunctions and immune suppression (CHAOS) [5].
These local and systemic pathophysiological changes that occur in polytrauma (CHAOS) eventually lead to Acute Kidney Injury (AKI) which further worsens their outcomes [6,7].
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nermeen Gamal
- Phone Number: 01274524886
- Email: nermeen.14224153@med.aun.edu.eg
Study Contact Backup
- Name: Omar Ibrahim
- Phone Number: 0 102 907 6733
- Email: omaribrahim726@icloud.com
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
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult polytrauma patients above 16 years old with no history of renal disease or chronic illness
Description
Inclusion Criteria:
- The present study will be conducted on patients with multiple trauma of both genders "without intently selected certain gender" who have no previous history of kidney disease or chronic illness.
Exclusion Criteria:
• Patients who are less than 16 years old.
- Patients with preexisting kidney disease or localized individual trauma.
- patients with diabetes and hypertension.
- Patients Post cardiac arrest
- patients leaving the hospital on the same day or transferred to a different hospital will be excluded from this study.
- patients refusing study will be excluded.
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 |
Measure Description |
Time Frame |
---|---|---|
Determine the incidence of acute kidney injury in poly trauma patients
Time Frame: 7 days
|
To identify the incidence and factors associated with acute kidney injury in adult polytrauma patients
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Omar Ibrahim, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Estimated)
November 1, 2023
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 25, 2023
First Submitted That Met QC Criteria
October 25, 2023
First Posted (Actual)
October 31, 2023
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acute kidney injury in trauma
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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