- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07546448
Serum Electrolytes and Contrast-Induced Nephropathy in Acute Ischemic Stroke Patients Undergoing Endovascular Treatment
The Impact of Serum Electrolyte Levels on the Risk of Contrast-Induced Nephropathy in Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy
This study aims to evaluate the relationship between serum electrolyte levels and the development of contrast-induced acute kidney injury (CI-AKI) in patients with acute ischemic stroke undergoing endovascular therapy (EVT).
Contrast-induced nephropathy remains a significant complication associated with endovascular procedures and is linked to increased morbidity and mortality. While several risk factors have been identified, the role of serum electrolyte imbalances in the development of CI-AKI has not been fully elucidated.
In this retrospective cohort study, patients treated with EVT between 2018 and 2026 will be analyzed. Patients will be classified based on the presence or absence of CI-AKI according to changes in serum creatinine levels. Demographic data, comorbidities, laboratory parameters-including serum electrolytes-and procedural variables will be compared between groups.
The primary objective is to determine whether serum electrolyte levels are associated with the risk of CI-AKI. Secondary objectives include evaluating 90-day mortality and dialysis dependency in patients who develop CI-AKI.
Study Overview
Status
Intervention / Treatment
Detailed Description
This retrospective cohort study is designed to evaluate the association between serum electrolyte levels and the development of contrast-induced acute kidney injury (CI-AKI) in patients undergoing endovascular therapy (EVT) for acute ischemic stroke.
Endovascular treatment has become a standard of care for acute ischemic stroke; however, the use of iodinated contrast media carries a risk of nephrotoxicity. Contrast-induced acute kidney injury remains a clinically significant complication and is associated with prolonged hospitalization, increased healthcare costs, and higher mortality rates. Although several well-established risk factors for CI-AKI have been identified, including baseline renal dysfunction, diabetes mellitus, and contrast volume, the role of serum electrolyte imbalances has not been clearly defined.
Electrolyte disturbances may influence renal perfusion, tubular function, and systemic hemodynamics, potentially contributing to the pathophysiology of CI-AKI. Therefore, identifying electrolyte-related risk factors may help improve risk stratification and guide preventive strategies in high-risk populations.
In this study, patients who underwent EVT between 2018 and 2026 will be included. Prospectively collected clinical data will be analyzed retrospectively. Patients will be divided into two groups based on the development of CI-AKI, defined according to changes in serum creatinine levels following contrast exposure.
Comparative analyses will be performed between patients with and without CI-AKI to identify potential predictors. Multivariate regression analysis may be used to determine independent risk factors associated with CI-AKI development.
The findings of this study are expected to provide clinically relevant insights into the role of electrolyte balance in the development of CI-AKI and may contribute to improved peri-procedural risk assessment and patient management strategies in acute ischemic stroke populations undergoing endovascular therapy.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatma Acil, M.D.
- Phone Number: +905337225225
- Email: acilfatma@gmail.com
Study Contact Backup
- Name: Abdulkadir Yektaş, Prof.Dr.
- Phone Number: +905053881884
- Email: akyektas722000@yahoo.com
Study Locations
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Outside of the US
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Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
- Fatma Acil
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Contact:
- Abdulkadir Yektaş, Prof.Dr.
- Phone Number: +905053881884
- Email: akyektas722000@yahoo.co.uk
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Contact:
- Fatma Acil, M.D.
- Phone Number: 05337225225
- Email: acilfatma@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
This study includes adult patients (≥18 years) with acute ischemic stroke who underwent endovascular therapy at a tertiary referral center between 2018 and 2026. Patients with sufficient clinical and laboratory data, including pre- and post-procedural serum creatinine measurements, will be eligible for inclusion.
The cohort reflects a real-world population of patients undergoing EVT, encompassing a wide range of demographic and clinical characteristics, including common vascular comorbidities. Patients will be stratified according to the development of contrast-induced acute kidney injury (CI-AKI) for comparative analyses.
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Patients diagnosed with acute ischemic stroke
- Patients who underwent endovascular therapy for acute ischemic stroke between 2018 and 2026
- Patients with a baseline NIHSS score of 6 or higher
- Patients who received iodinated contrast medium during the endovascular procedure
- Patients managed under general anesthesia
- Patients with available pre-procedural and post-procedural serum creatinine measurements sufficient to assess contrast-induced acute kidney injury
Exclusion Criteria:
- Age younger than 18 years
- Pre-existing acute kidney injury or chronic kidney disease meeting KDIGO stage 1-3 before endovascular therapy
- APACHE score greater than 25 at the time of the procedure
- Known allergy or hypersensitivity to iodinated contrast media
- Exposure to iodinated contrast media within the previous 2 weeks
- Use of nephrotoxic medications within the previous 2 weeks
- History of myocardial infarction or previous stroke
- Use of vasopressor/inotropic agents such as dopamine at the time of the procedure
- Systemic steroid use at the time of the procedure
- Incomplete medical records or missing laboratory data required for evaluation of CI-AKI
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CI-AKI Group
Patients who developed contrast-induced acute kidney injury (CI-AKI) following endovascular therapy for acute ischemic stroke, defined by an increase in serum creatinine levels according to established diagnostic criteria after contrast exposure.
These patients were identified based on post-procedural renal function changes and included in the analysis to evaluate clinical, laboratory, and procedural factors associated with CI-AKI development.
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No experimental or therapeutic intervention was assigned.
This observational retrospective cohort study evaluated patients undergoing endovascular therapy for acute ischemic stroke, who were subsequently categorized based on the presence or absence of contrast-induced acute kidney injury (CI-AKI).
The study analyzed demographic, clinical, laboratory (including serum electrolyte levels) and procedural variables to identify potential risk factors associated with CI-AKI development.
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|
Non-CI-AKI Group
Patients who underwent endovascular therapy for acute ischemic stroke but did not develop contrast-induced acute kidney injury based on post-procedural serum creatinine measurements.
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No experimental or therapeutic intervention was assigned.
This observational retrospective cohort study evaluated patients undergoing endovascular therapy for acute ischemic stroke, who were subsequently categorized based on the presence or absence of contrast-induced acute kidney injury (CI-AKI).
The study analyzed demographic, clinical, laboratory (including serum electrolyte levels) and procedural variables to identify potential risk factors associated with CI-AKI development.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of contrast-induced acute kidney injury (CI-AKI)
Time Frame: Within 48-72 hours after contrast exposure
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CI-AKI will be identified based on post-procedural serum creatinine changes after contrast exposure according to established diagnostic criteria.
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Within 48-72 hours after contrast exposure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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90-day mortality
Time Frame: Within 90 days after endovascular therapy
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All-cause mortality occurring within 90 days after endovascular therapy in patients with and without contrast-induced acute kidney injury (CI-AKI).
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Within 90 days after endovascular therapy
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Dialysis dependency in patients with CI-AKI
Time Frame: Within 90 days after endovascular therapy
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Requirement for renal replacement therapy (hemodialysis) within 90 days after endovascular therapy in patients who developed contrast-induced acute kidney injury (CI-AKI)
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Within 90 days after endovascular therapy
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Change in serum creatinine
Time Frame: Baseline to 48-72 hours after endovascular therapy
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Change in serum creatinine levels from baseline to post-procedural measurements following contrast exposure.
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Baseline to 48-72 hours after endovascular therapy
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Association between serum electrolyte levels and CI-AKI
Time Frame: Baseline (pre-procedural measurements)
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Evaluation of the relationship between baseline serum electrolyte levels (sodium, potassium, chloride, calcium, magnesium, phosphate) and the development of contrast-induced acute kidney injury.
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Baseline (pre-procedural measurements)
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Length of hospital stay
Time Frame: Within 90 days after endovascular therapy
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Total duration of hospitalization in days, compared between patients with and without CI-AKI.
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Within 90 days after endovascular therapy
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Inflammatory markers and CI-AKI relationship
Time Frame: Baseline (pre-procedural measurements)
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Association between inflammatory markers (e.g., C-reactive protein, procalcitonin) and the development of CI-AKI.
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Baseline (pre-procedural measurements)
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Change in estimated glomerular filtration rate (eGFR)
Time Frame: Baseline to 48-72 hours after endovascular therapy
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Change in estimated glomerular filtration rate (eGFR) from baseline to post-procedural measurements following contrast exposure
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Baseline to 48-72 hours after endovascular therapy
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Renal Insufficiency
- Stroke
- Ischemic Stroke
- Acute Kidney Injury
Other Study ID Numbers
- 27.012.2026-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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