Cystatin c: a Biomarker of AKI in Aneurysmal Subarachnoid Haemorrhage Patients

April 21, 2025 updated by: Ahmed Ayman, Alexandria University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21648
        • Faculty of medicine, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Aneurysmal subarachnoid hemorrhage patients

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aki group
Cystatin c biomarker will be assessed to predict occurrence of early acute kidney injury
Diagnostic test: cystatin c
a biomarker to assess renal function
Non-Aki group
participants in this group will not develop acute kidney injury throughout the study duration
Diagnostic test: cystatin c
a biomarker to assess renal function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: 6 days
stages "risk" and "injury" are considered early AKI
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse neurological outcomes
Time Frame: 10 days all except mortality within 28 days
Delayed cerebral ischemia Angiographic vasospasm Hydrocephalus Infection Mortality
10 days all except mortality within 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Mohamed A El Erian, Professor, Alexandria University
  • Study Chair: Ashraf A Abdelhalim, Professor, Alexandria University
  • Study Chair: Sherif M El Hadi, Professor, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9222704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I keep the IPD information of study participants, based on principle of confidentiality Disclosure after participant permission is allowed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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