"Role of Biomarkers in Predicting Contrast-induced Acute Kidney Injury in Critically Ill Patients: a Prospective Observational Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- To analyse the role of plasma and urinary biomarkers (Neutrophil Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in predicting contrast-induced acute kidney injury (CI-AKI) in critically ill patients.
研究概览
简要总结
Title: "Role of biomarkers in predicting contrast-induced acute kidney injury in critically ill patients: a prospective observational study"
Objective: To analyse the role of plasma and urinary biomarkers (Neutrophil Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in predicting contrast-induced acute kidney injury (CI-AKI) in critically ill patients.
Summary of the project:
Acute deterioration of renal function after intravenous administration of radiocontrast media, i.e. increase in serum creatinine concentration of more than 0.5 mg/dl or 25% above baseline within 48 hours, is referred to as contrast-induced kidney injury (CI-AKI). The increasing number of diagnostic procedures requiring radiographic contrast has parallel increase in the incidence of CI-AKI. CI-AKI is described as the third most common cause of new AKI in hospitalized patients. Occurrence of CI-AKI is reported up to 55% in high risk patients like presence pre-existing chronic renal dysfunction, diabetes, hypertension, chronic heart failure, advanced age, volume depletion, uses of concurrent nephrotoxic medication. These risk factors for CI-AKI are common in critically ill patients. Recently, different urinary and serum proteins have been intensively investigated as possible biomarkers for the early diagnosis of AKI, which includes Neutrophil Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1 (KIM 1). At present, there is scarcity of prospective study on CI-AKI and role of biomarkers in critically ill medical or medical-surgical mixed ICU patients.
The investigators plan to enroll about 100 ICU patients during 2 years, requiring computed tomography (CT) scans with parenteral administration of iodinated radiographic contrast for any diagnostic purposes as decided by the clinicians during the treatment of the patients. In this prospective observation study, the investigators want to analyse the role of plasma and urinary biomarkers in predicting CI-AKI in critically ill patients.
Key Words: acute kidney injury, radiographic contrast, critically ill, biomarker
详细描述
Rationale of the study supported by cited literature:
Role of biomarkers in AKI has been established in different clinical settings, to not only early diagnosis but also make prognosis. There are some studies in contrast-induced AKI, mainly in patients undergoing cardiac catheterization. Due to scarcity of prospective studies on this clinically important issue in critically ill patients, there is a need for this proposed study. The investigators will do study to analyse the role of plasma and urinary biomarkers (Neutrophil Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in predicting CI-AKI in critically ill patients
The relevance and expected outcome of the proposed study:
With this study, the investigators will be able to know that is there any predictive value of these biomarkers to predict CI-AKI in critically ill patients.
Preliminary work done so far:
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
- 否
入选标准
- •All ICU patients who are > 18 years and having normal renal function, requiring radiographic contrast for diagnostic or interventional computed tomography procedure, will be considered for inclusion.
排除标准
- •Age <18 years
- •Known Chronic Kidney Disease
- •Patient already on dialysis
- •Presence of Acute Kidney Injury (increase in SCr by 50% or decrease in GFR by 25% within last 7 days)
- •Recent exposure to radiographic contrast within 3 days of the study
- •History of cardio/respiratory arrest during current illness
- •Increase in serum creatinine levels of ≥ 0.3 mg/dl from the baseline during the previous 48 hours before contrast exposure.
- •Known or suspected nephritic or nephrotic syndrome.
- •A post-renal etiology of renal impairment
- •Known allergy or hypersensitivity to radiographic contrast dye
- •Pregnancy
结局指标
主要结局
To analyse the role of plasma and urinary biomarkers (Neutrophil Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in predicting contrast-induced acute kidney injury (CI-AKI) in critically ill patients.
时间窗: 48 Hours after contrast exposure
Correlate levels of biomarkers in plasma and urine at different time interval in patients who develop contrast-induced acute kidney injury
次要结局
未报告次要终点