Kidney InjuryNCT06108765
Acute Kidney Injury in Poly Trauma Patients
An observational study of Kidney Injury, run by Assiut University.
Trial summary
The aim of this study is to identify the incidence and the factors associated with acute kidney injury in adult poly trauma patients Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Kidney Injury
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Dec 2024
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult polytrauma patients above 16 years old with no history of renal disease or chronic illness
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to identify the incidence and the factors associated with acute kidney injury in adult poly trauma patients
Read the 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].
- Conditions
- Kidney Injury
- Keywords
- Polytrauma
- Medical subject headings
- Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the incidence of acute kidney injury in poly trauma patients
To identify the incidence and factors associated with acute kidney injury in adult polytrauma patients
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar ibrahim abd elsalam, Assiut University
- Investigators
- Omar Ibrahim, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108765
- Sponsor's protocol ID
- Acute kidney injury in trauma
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopes JA, Jorge S. The RIFLE and AKIN classifications for acute kidney injury: a critical and comprehensive review. Clin Kidney J. 2013 Feb;6(1):8-14. doi: 10.1093/ckj/sfs160. Epub 2012 Jan 1.
PubMed 27818745
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Poly Trauma Patients
- ClinicalTrials.gov ID
- NCT06108765
- Acronym / sponsor ID
- Acute kidney injury in trauma
- Conditions
- Kidney Injury
- Keywords
- Polytrauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 31 Oct 2023 (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.
The aim of this study is to identify the incidence and the factors associated with acute kidney injury in adult poly trauma patients
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult polytrauma patients above 16 years old with no history of renal disease or chronic illness
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- • Patients who are less than 16 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 27818745Lopes JA, Jorge S. The RIFLE and AKIN classifications for acute kidney injury: a critical and comprehensive review. Clin Kidney J. 2013 Feb;6(1):8-14. doi: 10.1093/ckj/sfs160. Epub 2012 Jan 1.
Related trials for Kidney Injury
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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.
Omar Ibrahim study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, run by Assiut University.
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 1 inclusion and 6 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 31 Oct 2023. 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 Nermeen Gamal (01274524886, nermeen.14224153@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the incidence of acute kidney injury in poly trauma patients (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108765, which also lists 1 linked publication.
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 31 Oct 2023.