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临床试验/NCT07713524
NCT07713524已完成不适用

Repeated Contrast Exposure and Kidney Outcomes in Critically Ill Patients With Pre-Existing Renal Dysfunction: A Prospective Cohort Study

Cairo University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
Contrast-associated AKI [ Acute Kidney Injury ] defined by KDIGO [Kidney Disease Improving Global Outcomes] criteria

研究概览

简要总结

Aim of study: The renal impact of repeated iodinated contrast exposure in critically ill patients with pre-existing renal impairment

Methods: A prospective observational cohort study included 112 critically ill patients admitted to the intensive care units of Cairo University hospitals with baseline estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m² who underwent one or two intravascular iodinated contrast administrations. Hemodynamically unstable patients were excluded. Patients were systematically followed to evaluate both short- and long-term renal outcomes. Serum creatinine, eGFR, urine output, contrast-associated acute kidney injury (CA-AKI), chronic kidney disease (CKD) progression and dialysis requirement were assessed after each exposure and during 6 months follow-up. Logistic regression analysis was performed.

详细描述

Methodology

Study design, recruitment and study location: This is a prospective observational cohort study. Patients were consecutively recruited from the intensive care units of Cairo University hospitals between March 2024 and November 2025 and were followed after discharge through outpatient clinics, in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. The study protocol approved by the Faculty of Medicine, Cairo University Research Ethics Committee, on 13-1-2024, with the approval number N-20-2024.

Exposure groups: Participants were categorized into two groups according to the number of intravascular contrast administrations received during the study period into two groups.

  • Group I: patients who underwent a single contrast exposure with impaired kidney function.
  • Group II: Patients who received two contrast administrations with impaired kidney function.

Data collection: For the enrolled patients, baseline variables were extracted from the hospital database. Before any data handling or analysis, all records were comprehensively anonymized to ensure confidentiality. Collected data included demographic characteristics (age, sex, and body mass index), clinical parameters (blood pressure, primary diagnosis, cause of ICU admission, CKD stage, smoking status), comorbid conditions (diabetes mellitus, hypertension, heart failure/cardiovascular disease, liver disease, previous stroke and dyslipidemia) and medication history (angiotensin converting enzyme inhibitors/angiotensin receptor blockers, sodium-glucose cotransporter 2 inhibitors, and statins).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older with baseline eGFR <90 mL/min/1.73 m² who underwent at least one intravascular iodinated contrast study

排除标准

  • Kidney transplant within the preceding 6 months
  • Ongoing renal replacement therapy
  • Hemodynamic shock
  • Severe sepsis
  • Recent nephrotoxic drug exposure
  • Incomplete laboratory data
  • Prior contrast allergy.

研究组 & 干预措施

a single-exposure group

patients who underwent a single contrast exposure with impaired kidney function.

a repeated-exposure group

Patients who received two contrast administrations with impaired kidney function.

结局指标

主要结局

Contrast-associated AKI [ Acute Kidney Injury ] defined by KDIGO [Kidney Disease Improving Global Outcomes] criteria

时间窗: 3 months

次要结局

  • Progression of CKD stage(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Farouk

Associate professor

Cairo University

研究点 (1)

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