Acute Kidney InjuryNCT06791200
Role of Some Biochemical Indices for Prediction of Acute Kidney Injury in Intensive Care Unit Patients in Upper Egypt
An observational study of Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
Trial summary
1. We will investigate the relation between the triglyceride-glucose index and the development of AKI in ICU. 2. To detect whether the TGI is a predictor of poor outcome (requirement of renal replacement therapy, or 14-day in-hospital mortality, and length of hospital stay) in ICU. 3. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- biochemical indices
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The selected patients will be with the following inclusion criteria: Patients admitted to ICU within 24 hours
Who may be able to join
- The selected patients will be with the following inclusion criteria:
- Patients admitted to ICU within 24 hours
Who cannot join
- We will exclude those with any of the following:
- Patients diagnosed more than 24 hours.
- Patients with missing data of triglyceride or glucose.
- Patients \<18years old.
- patient with advanced liver disease and chronic kidney disease with or without dialysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ehdaa Ahmed Sanosy a Ehdaa Sanosy, Resident in Internal Medicine contact
Prof. Dr. Lobna Farrag El Toony f El Toony, Professor of Internal Medicine contact
About this study
- We will investigate the relation between the triglyceride-glucose index and the development of AKI in ICU.
- To detect whether the TGI is a predictor of poor outcome (requirement of renal replacement therapy, or 14-day in-hospital mortality, and length of hospital stay) in ICU.
- Compare TGL, Neutrophil-to-lymphocyte ratio, and clinical score (sequential organ failure assessment SOFA score) as predictors of poor outcome in ICU.
Read the detailed description
Acute kidney injury (AKI) is a common clinical syndrome with a broad aetiological profile. It complicates about 5% of hospital admissions and 30% of admissions to intensive care units (ICU). During last 20 years has been a significant change in the spectrum of severe AKI such that it is no longer mostly a single organ phenomenon but rather a complex multisystem clinical problem. mortality from AKI, when part of MOF, remains over 50%.
In the past few decades, the understanding of AKI has greatly improved, but early diagnosis remains a great challenge. The performance of traditional kidney function index and serum creatinine is very limited for the early diagnosis of acute kidney injury The triglyceride glucose index (TGI) has been suggested as a useful marker of insulin resistance. Previous studies have shown that TGI is associated with many diseases, but no study has examined the relationship between TGI and Aki .
the primary objective of the present study was to investigate the relationship between TGI and Aki.
- Conditions
- Acute Kidney Injury
- Being tested
- biochemical indices
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biochemical indicesDiagnostic test
some biochemical indices for prediction of Acute kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
TGI
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (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 Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehdaa Ahmed Sanosy Mohamed, Assiut University
- Investigators
- Dr. Taghreed Sayed Mohamed Meshref s Meshref, Lecturer of Critical care med, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791200
- Sponsor's protocol ID
- prediction of AKI in icu
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Birkelo BC, Pannu N, Siew ED. Overview of Diagnostic Criteria and Epidemiology of Acute Kidney Injury and Acute Kidney Disease in the Critically Ill Patient. Clin J Am Soc Nephrol. 2022 May;17(5):717-735. doi: 10.2215/CJN.14181021. Epub 2022 Mar 15.
PubMed 35292532
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Some Biochemical Indices for Prediction of Acute Kidney Injury in Intensive Care Unit Patients in Upper Egypt
- ClinicalTrials.gov ID
- NCT06791200
- Acronym / sponsor ID
- prediction of AKI in icu
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
- We will investigate the relation between the triglyceride-glucose index and the development of AKI in ICU.
- To detect whether the TGI is a predictor of poor outcome (requirement of renal replacement therapy, or 14-day in-hospital mortality, and length of hospital stay) in ICU.
- Compare TGL, Neutrophil-to-lymphocyte ratio, and clinical score (sequential organ failure assessment SOFA score) as predictors of poor outcome in ICU.
Detailed description
Acute kidney injury (AKI) is a common clinical syndrome with a broad aetiological profile. It complicates about 5% of hospital admissions and 30% of admissions to intensive care units (ICU). During last 20 years has been a significant change in the spectrum of severe AKI such that it is no longer mostly a single organ phenomenon but rather a complex multisystem clinical problem. mortality from AKI, when part of MOF, remains over 50%.
In the past few decades, the understanding of AKI has greatly improved, but early diagnosis remains a great challenge. The performance of traditional kidney function index and serum creatinine is very limited for the early diagnosis of acute kidney injury The triglyceride glucose index (TGI) has been suggested as a useful marker of insulin resistance. Previous studies have shown that TGI is associated with many diseases, but no study has examined the relationship between TGI and Aki .
the primary objective of the present study was to investigate the relationship between TGI and Aki.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The selected patients will be with the following inclusion criteria: Patients admitted to ICU within 24 hours
Key inclusion criteria (2 listed)
- The selected patients will be with the following inclusion criteria:
- Patients admitted to ICU within 24 hours
Key exclusion criteria (5 listed)
- We will exclude those with any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biochemical indicessome biochemical indices for prediction of Acute kidney Injury | Diagnostic test | – |
Primary outcome
TGI
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Results publication: PubMed 35292532Birkelo BC, Pannu N, Siew ED. Overview of Diagnostic Criteria and Epidemiology of Acute Kidney Injury and Acute Kidney Disease in the Critically Ill Patient. Clin J Am Soc Nephrol. 2022 May;17(5):717-735. doi: 10.2215/CJN.14181021. Epub 2022 Mar 15.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Ehdaa Ahmed Sanosy a Ehdaa Sanosy, Resident in Internal Medicine contact
Prof. Dr. Lobna Farrag El Toony f El Toony, Professor of Internal Medicine contact
Dr. Taghreed Sayed Mohamed Meshref s Meshref, Lecturer of Critical care med study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ehdaa Ahmed Sanosy a Ehdaa Sanosy, Resident in Internal Medicine (+20 1122322491, ehdaa00sanosy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TGI (time frame: baseline). 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 NCT06791200, 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 24 Jan 2025.