Acute Kidney InjuryNCT06584149
BAR As a Mortality Predictor in Septic AKI
An observational study of Acute Kidney Injury and Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the prognostic value of Blood Urea Nitrogen to serum Albumin ratio in septic Acute Kidney Injury patients Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Kidney Injury, Sepsis
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2023to 25 Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This prospective study will be conducted on patients with septic acute kidney injury. After admission of the patient to ICU in Ain Shams University Hospitals
Who may be able to join
- 18 - 60 years of age
- Fulfilled the diagnostic criteria of Sepsis 3.0 (defined as a suspected or confirmed infection with a sequential organ failure assessment (SOFA) score of 2 or higher)
- Developed AKI during hospitalization according to Kidney Disease: Improving Global Outcomes (KDIGO) guideline
Who cannot join
- ICU length of stay<24 h
- AKI occurred before current hospital admission.
- AKI is supposed to be secondary to causes other than sepsis.
- Receiving renal replacement therapy at the time of admission.
- Diagnosis with chronic kidney disease.
- Diagnosis with liver failure.
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- Pregnant or lactating.
- There was insufficient data for analysis.
- Patients who had received Human serum Albumin infusion 3 days before ICU admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Blood Urea Nitrogen to Serum Albumin Ratio in the Prediction of Mortality in Septic Acute Kidney Injury Patients
The aim of this study is to investigate the prognostic value of Blood Urea Nitrogen to serum Albumin ratio in septic Acute Kidney Injury patients Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.
Read the detailed description
A complete medical history will be obtained from all patients including age, sex, comorbidities, cause of sepsis, and SOFA and APACHE II scores at admission.
Blood samples will be collected within 24 hours of AKI diagnosis for analysis of Blood Urea Nitrogen (BUN) and serum Albumin levels.
Blood Urea Nitrogen to serum Albumin ratio (B/A) will be calculated by dividing the BUN of a patient by their serum Albumin levels.
Laboratory parameters also will include pH, lactate (Lac), base excess (BE), hemoglobin (Hb), platelet (PLT) count, white blood cell (WBC) count, bilirubin, hematocrit (HCT), creatinine (Cr), serum sodium (Na), serum potassium (K), serum calcium (Ca), serum magnesium (Mg), triglyceride (TG), aspartate aminotransferase (ALT), alanine aminotransferase (AST), prothrombin time (PT), and activated partial thromboplastin time (APTT) values.
Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.
Study population will be divided into survival and non-survival groups based on their 30-day survival status
- Conditions
- Acute Kidney Injury, Sepsis
- Medical subject headings
- Acute Kidney Injury, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
number of cases of mortality
Measured: 30 days
Secondary outcomes (5)
mechanical ventilation
number of participants who needed mechanical ventilation
Measured: 30 days
stage-3 AKI
number of participants who developed stage-3 AKI
Measured: 30 days
renal replacement therapy
number of participants who needed renal replacement therapy
Measured: 30 days
septic shock
number of participants who developed septic shock
Measured: 30 days
length of ICU stay
length of ICU stay in days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start25 Sep 2023
- Primary completion1 Jun 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584149
- Sponsor's protocol ID
- BAR in septic AKI
- Status last verified
- Jul 2024
- First submitted
- 24 Aug 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Blood Urea Nitrogen to Serum Albumin Ratio in the Prediction of Mortality in Septic Acute Kidney Injury Patients
- ClinicalTrials.gov ID
- NCT06584149
- Acronym / sponsor ID
- BAR in septic AKI
- Conditions
- Acute Kidney Injury, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 4 Sep 2024 (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 investigate the prognostic value of Blood Urea Nitrogen to serum Albumin ratio in septic Acute Kidney Injury patients Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.
Detailed description
A complete medical history will be obtained from all patients including age, sex, comorbidities, cause of sepsis, and SOFA and APACHE II scores at admission.
Blood samples will be collected within 24 hours of AKI diagnosis for analysis of Blood Urea Nitrogen (BUN) and serum Albumin levels.
Blood Urea Nitrogen to serum Albumin ratio (B/A) will be calculated by dividing the BUN of a patient by their serum Albumin levels.
Laboratory parameters also will include pH, lactate (Lac), base excess (BE), hemoglobin (Hb), platelet (PLT) count, white blood cell (WBC) count, bilirubin, hematocrit (HCT), creatinine (Cr), serum sodium (Na), serum potassium (K), serum calcium (Ca), serum magnesium (Mg), triglyceride (TG), aspartate aminotransferase (ALT), alanine aminotransferase (AST), prothrombin time (PT), and activated partial thromboplastin time (APTT) values.
Follow-up will be conducted for all enrolled patients for 30 days from admission to record mortality and the cause of death.
Study population will be divided into survival and non-survival groups based on their 30-day survival status
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This prospective study will be conducted on patients with septic acute kidney injury. After admission of the patient to ICU in Ain Shams University Hospitals
Key inclusion criteria (3 listed)
- 18 - 60 years of age
- Fulfilled the diagnostic criteria of Sepsis 3.0 (defined as a suspected or confirmed infection with a sequential organ failure assessment (SOFA) score of 2 or higher)
- Developed AKI during hospitalization according to Kidney Disease: Improving Global Outcomes (KDIGO) guideline
Key exclusion criteria (9 listed)
- ICU length of stay<24 h
- AKI occurred before current hospital admission.
- AKI is supposed to be secondary to causes other than sepsis.
- Receiving renal replacement therapy at the time of admission.
- Diagnosis with chronic kidney disease.
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
mortality
Time frame: 30 days
number of cases of mortality
5 secondary outcomes
mechanical ventilation
Time frame: 30 days
stage-3 AKI
Time frame: 30 days
renal replacement therapy
Time frame: 30 days
septic shock
Time frame: 30 days
length of ICU stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Sepsis, run by Ain Shams 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 17 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2025.