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

Active, not recruiting

• Conditions: Acute Kidney Injury
• Interventions: Diagnostic Test: cystatin c

• Registration Number: NCT06635408
• Lead Sponsor: Alexandria University

Brief 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?

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-01-01
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aki group	cystatin c	Cystatin c biomarker will be assessed to predict occurrence of early acute kidney injury
Non-Aki group	cystatin c	participants in this group will not develop acute kidney injury throughout the study duration

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	6 days	stages "risk" and "injury" are considered early AKI

Secondary Outcome Measures

Name	Time	Method
Adverse neurological outcomes	10 days all except mortality within 28 days	Delayed cerebral ischemia Angiographic vasospasm Hydrocephalus Infection Mortality

Trial Locations

Locations (1)

Faculty of medicine, Alexandria University; 🇪🇬 Alexandria, Egypt