NCT06635408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

October 7, 2024

Last Update Submit

April 21, 2025

Conditions

Acute Kidney Injury

Keywords

Acute kidney injuryDelayed cerebral ischemiaAngiographic vasospasmAneurysmal subarachnoid hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    stages "risk" and "injury" are considered early AKI

    6 days

Secondary Outcomes (1)

  • Adverse neurological outcomes

    10 days all except mortality within 28 days

Study Arms (2)

Aki group

Cystatin c biomarker will be assessed to predict occurrence of early acute kidney injury

Diagnostic Test: cystatin c

Non-Aki group

participants in this group will not develop acute kidney injury throughout the study duration

Diagnostic Test: cystatin c

Interventions

cystatin cDIAGNOSTIC_TEST

a biomarker to assess renal function

Aki groupNon-Aki group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Aneurysmal subarachnoid hemorrhage patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine, Alexandria University

Alexandria, 21648, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33478333BACKGROUND

Related Links

MeSH Terms

Conditions

Acute Kidney InjurySubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed A El Erian, Professor

    Alexandria University

    STUDY CHAIR

  • Ashraf A Abdelhalim, Professor

    Alexandria University

    STUDY CHAIR

  • Sherif M El Hadi, Professor

    Alexandria University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 10, 2024

Study Start

October 30, 2023

Primary Completion

January 1, 2025

Study Completion

January 15, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Locations

EG(1)