Acute Kidney InjuryNCT06635408
Cystatin c: a Biomarker of AKI in Aneurysmal Subarachnoid Haemorrhage Patients
An observational study of Acute Kidney Injury, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this observational study is to assess cystatin c as a predictive biomarker of early acute kidney injury in aneurysmal subarachnoid hemorrhage patients. The main question it aims to answer is: Does cystatin c biomarker can predict early acute kidney injury in aneurysmal subarachnoid hemorrhage patients?… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- cystatin c
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2023to 15 Jan 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Aneurysmal subarachnoid hemorrhage patients
Who may be able to join
- Patient admission to hospital within 48 hours of subarachnoid haemorrhage onset.
- Subarachnoid haemorrhage caused by intracranial aneurysm rupture and is confirmed via computed tomography angiography (CTA).
- Medical treatment, microsurgical clipping, or interventional endovascular treatment of aneurysm is performed within 48 hours of subarachnoid haemorrhage onset.
Who cannot join
- Prior onset of subarachnoid haemorrhage or other neurological diseases such as ischemic stroke, hemorrhagic stroke, or severe head trauma.
- Systemic diseases, such as chronic liver diseases, chronic lung diseases, chronic heart failure, thyroid diseases and cancer.
- Renal impairment at time of admission (creatinine-based eGFR less than 60 ml/min per 1.73 m2 body surface area).
- Patients who are hemodynamically unstable at time of admission.
- Mortality within 10 days after admission (duration of study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cystatin c as a Predictive Biomarker of Acute Kidney Injury and Neurological Outcomes in Aneurysmal Subarachnoid Haemorrhage Patients
The goal of this observational study is to assess cystatin c as a predictive biomarker of early acute kidney injury in aneurysmal subarachnoid hemorrhage patients. The main question it aims to answer is:
- Does cystatin c biomarker can predict early acute kidney injury in aneurysmal subarachnoid hemorrhage patients?
Participants will be grouped into Aki and Non-Aki groups based on RIFLE criteria and Cystatin c biomarker will be tested to answer the study question.
- Conditions
- Acute Kidney Injury
- Being tested
- cystatin c
- Keywords
- Acute kidney injury, Delayed cerebral ischemia, Angiographic vasospasm, Aneurysmal subarachnoid hemorrhage
- Medical subject headings
- Acute Kidney Injury, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystatin cDiagnostic test
a biomarker to assess renal function
| Study group | Role | What they receive |
|---|---|---|
| Aki group | Cystatin c biomarker will be assessed to predict occurrence of early acute kidney injury Receives: Diagnostic Test: cystatin c | |
| Non-Aki group | participants in this group will not develop acute kidney injury throughout the study duration Receives: Diagnostic Test: cystatin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
stages "risk" and "injury" are considered early AKI
Measured: 6 days
Secondary outcomes (1)
Adverse neurological outcomes
Delayed cerebral ischemia Angiographic vasospasm Hydrocephalus Infection Mortality
Measured: 10 days all except mortality within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start30 Oct 2023
- Primary completion1 Jan 2025
- Study completion15 Jan 2025
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 Alexandria 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ayman, Alexandria University
- Investigators
- Mohamed A El Erian, Professor, Study chair, Alexandria UniversityAshraf A Abdelhalim, Professor, Study chair, Alexandria UniversitySherif M El Hadi, Professor, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635408
- Sponsor's protocol ID
- 9222704
- Status last verified
- Apr 2025
- First submitted
- 7 Oct 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I keep the IPD information of study participants, based on principle of confidentiality Disclosure after participant permission is allowed
Publications
Wang RR, He M, Gui X, Kang Y. A nomogram based on serum cystatin C for predicting acute kidney injury in patients with traumatic brain injury. Ren Fail. 2021 Dec;43(1):206-215. doi: 10.1080/0886022X.2021.1871919.
PubMed 33478333
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystatin c as a Predictive Biomarker of Acute Kidney Injury and Neurological Outcomes in Aneurysmal Subarachnoid Haemorrhage Patients
- ClinicalTrials.gov ID
- NCT06635408
- Acronym / sponsor ID
- 9222704
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Delayed cerebral ischemia, Angiographic vasospasm, Aneurysmal subarachnoid hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 10 Oct 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 goal of this observational study is to assess cystatin c as a predictive biomarker of early acute kidney injury in aneurysmal subarachnoid hemorrhage patients. The main question it aims to answer is:
- Does cystatin c biomarker can predict early acute kidney injury in aneurysmal subarachnoid hemorrhage patients?
Participants will be grouped into Aki and Non-Aki groups based on RIFLE criteria and Cystatin c biomarker will be tested to answer the study question.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aki group | – | Diagnostic Test: cystatin cCystatin c biomarker will be assessed to predict occurrence of early acute kidney injury |
| Non-Aki group | – | Diagnostic Test: cystatin cparticipants in this group will not develop acute kidney injury throughout the study duration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Aneurysmal subarachnoid hemorrhage patients
Key inclusion criteria (3 listed)
- Patient admission to hospital within 48 hours of subarachnoid haemorrhage onset.
- Subarachnoid haemorrhage caused by intracranial aneurysm rupture and is confirmed via computed tomography angiography (CTA).
- Medical treatment, microsurgical clipping, or interventional endovascular treatment of aneurysm is performed within 48 hours of subarachnoid haemorrhage onset.
Key exclusion criteria (5 listed)
- Prior onset of subarachnoid haemorrhage or other neurological diseases such as ischemic stroke, hemorrhagic stroke, or severe head trauma.
- Systemic diseases, such as chronic liver diseases, chronic lung diseases, chronic heart failure, thyroid diseases and cancer.
- Renal impairment at time of admission (creatinine-based eGFR less than 60 ml/min per 1.73 m2 body surface area).
- Patients who are hemodynamically unstable at time of admission.
- Mortality within 10 days after admission (duration of study).
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 |
|---|---|---|
| cystatin ca biomarker to assess renal function | Diagnostic test | Aki group, Non-Aki group |
Primary outcome
Acute kidney injury
Time frame: 6 days
stages "risk" and "injury" are considered early AKI
1 secondary outcome
Adverse neurological outcomes
Time frame: 10 days all except mortality within 28 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 24 Apr 2025.
- Background: PubMed 33478333Wang RR, He M, Gui X, Kang Y. A nomogram based on serum cystatin C for predicting acute kidney injury in patients with traumatic brain injury. Ren Fail. 2021 Dec;43(1):206-215. doi: 10.1080/0886022X.2021.1871919.
- An nih linkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I keep the IPD information of study participants, based on principle of confidentiality Disclosure after participant permission is allowed
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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.
Mohamed A El Erian, Professor study chair
Alexandria University
Ashraf A Abdelhalim, Professor study chair
Alexandria University
Sherif M El Hadi, Professor study chair
Alexandria 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 Alexandria 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 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: finished, as of the sponsor's last update on 24 Apr 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?
Acute kidney injury (time frame: 6 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 NCT06635408, 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 Apr 2025.