Acute Kidney InjuryNCT03560921
Urinary NGAL Acute Kidney Injury After Stored Red Blood Cells Transfusion in Critically Ill Patients.
An observational study of Acute Kidney Injury and Anemia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The study aims to explore the association of the novel urinary bio marker NGAL with the age of PRBCs(packed red blood cells) transfusion in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Anemia
- What is being tested?
- urinary NGAL
- How many people
- 147 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2017to 5 Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to ICU of any age and sex
Who may be able to join
- Any patients admitted to the intensive care unit.
Who cannot join
- patients who have established AKI at the time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of NGAL With the Development of Acute Kidney Injury After Stored Red Blood Cells Transfusion in Critically Ill Patients.
The study aims to explore the association of the novel urinary bio marker NGAL with the age of PRBCs(packed red blood cells) transfusion in critically ill patients.
Read the detailed description
The investigators will measure the urinary NGAL in all patients who received blood transfusion in the intensive care unit during the study period. The age of PRBCs transfusion will be correlated with the incidence of AKI. The rise of NGAL and serum creatinine will be used to diagnose AKI (Acute Kidney Injury).
- Conditions
- Acute Kidney Injury, Anemia
- Being tested
- urinary NGAL
- Keywords
- biomarkers
- Medical subject headings
- Acute Kidney Injury, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary NGALDiagnostic test
measurement urinary NGAL using the ARCHITECT technique
| Study group | Role | What they receive |
|---|---|---|
| Stored blood transfusion | measurement of urinary NGAL Receives: Diagnostic Test: urinary NGAL | |
| Fresh blood transfusion | measurement of urinary NGAL Receives: Diagnostic Test: urinary NGAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI
Diagnosis of AKI by rise of serum creatinine
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start2 Jun 2017
- Primary completion5 Dec 2017
- Study completion5 Dec 2017
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.
- 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelziz, Kasr El Aini Hospital
- Investigators
- Tarek Abdelaziz, Principal investigator, faculty of medicine-Cairo University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560921
- Sponsor's protocol ID
- KA-13115
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of NGAL With the Development of Acute Kidney Injury After Stored Red Blood Cells Transfusion in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT03560921
- Acronym / sponsor ID
- KA-13115
- Conditions
- Acute Kidney Injury, Anemia
- Keywords
- biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 18 Jun 2018 (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 study aims to explore the association of the novel urinary bio marker NGAL with the age of PRBCs(packed red blood cells) transfusion in critically ill patients.
Detailed description
The investigators will measure the urinary NGAL in all patients who received blood transfusion in the intensive care unit during the study period. The age of PRBCs transfusion will be correlated with the incidence of AKI. The rise of NGAL and serum creatinine will be used to diagnose AKI (Acute Kidney Injury).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stored blood transfusion | – | Diagnostic Test: urinary NGALmeasurement of urinary NGAL |
| Fresh blood transfusion | – | Diagnostic Test: urinary NGALmeasurement of urinary NGAL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to ICU of any age and sex
Key inclusion criteria (1 listed)
- Any patients admitted to the intensive care unit.
Key exclusion criteria (1 listed)
- patients who have established AKI at the time of recruitment
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 |
|---|---|---|
| urinary NGALmeasurement urinary NGAL using the ARCHITECT technique | Diagnostic test | Fresh blood transfusion, Stored blood transfusion |
Primary outcome
Incidence of AKI
Time frame: within 30 days
Diagnosis of AKI by rise of serum creatinine
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 18 Jun 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tarek Abdelaziz principal investigator
faculty of medicine-Cairo University Hospitals
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 Anemia, run by Kasr El Aini Hospital 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 1 inclusion and 1 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 18 Jun 2018. 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?
Incidence of AKI (time frame: within 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 18 Jun 2018.