Epidemiology and Short-term Outcomes of Hospital-Acquired Acute Kidney Injury (AKI) in Critically Ill Adults: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- 1) To determine the incidence of hospital-acquired Acute Kidney Injury (AKI) in critically ill adult patients admitted to the Critical Care Unit (CCU)
研究概览
简要总结
Summary
This dissertation, titled “Epidemiology and Short-term Outcomes of Hospital-Acquired Acute Kidney Injury (AKI) in Critically Ill Adults: A Prospective Cohort Study”, addresses an important knowledge gap in the burden and prognosis of AKI in resource-limited settings. AKI, defined by KDIGO criteria, is a frequent complication in critically ill patients and is strongly associated with morbidity, mortality, and long-term progression to chronic kidney disease. However, there is limited high-quality, prospective data from India and other low- and middle-income countries (LMICs).
The study is designed as a prospective observational cohort enrolling adult patients admitted to the Critical Care Unit (CCU) of a tertiary care hospital. Patients with pre-existing AKI, CKD, renal transplantation, or terminal illness are excluded. Consecutive eligible patients will be followed from admission until 90 days post-discharge. Detailed demographic, clinical, and biochemical data will be collected, including severity scores (APACHE II, SOFA), hemodynamic support, ventilation parameters, and renal biomarkers. AKI will be defined and staged by KDIGO serum creatinine criteria, excluding urine output due to measurement limitations.
The primary objective is to determine the incidence of hospital-acquired AKI (HA-AKI). Secondary objectives include identifying epidemiological risk factors, evaluating outcomes such as length of stay, mechanical ventilation days, and mortality, and specifically assessing Major Adverse Kidney Events (MAKE-30 and MAKE-90)—a composite of death, new renal replacement therapy, or persistent renal dysfunction. Statistical analyses will include regression models for risk factor identification, survival analysis, and relative risk estimation.
The expected outcome is to provide robust epidemiological data on the incidence and short-term prognosis of HA-AKI in critically ill Indian patients. This work will contribute to early recognition, risk stratification, and management strategies, ultimately aiming to reduce AKI-related morbidity and mortality in similar clinical settings.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Hospitalized for more than 48 hours and Transferred to the Critical Care Unit (CCU).
排除标准
- •1.Pre-existing AKI- defined as an increase in serum creatinine of greater than or equal to 0.3 mg per dL from baseline within 48 hours during the hospital stay before CCU admission, or from any available prior outpatient creatinine measurements in non-hospitalized individuals 2.Chronic kidney disease (CKD), or end-stage renal disease (ESRD) patients 3.History of renal transplantation 4.Pregnant patients 5.Terminally ill patients with a life expectancy less than 48 hours 6.Patients transferred from other Intensive Care Units (ICUs) 7.Patients with less than 48 hours length of stay in the CCU.
结局指标
主要结局
1) To determine the incidence of hospital-acquired Acute Kidney Injury (AKI) in critically ill adult patients admitted to the Critical Care Unit (CCU)
时间窗: Baseline, after 48hrs.
次要结局
- 1) To identify & evaluate the risk factors for hospital-acquired Acute Kidney Injury (AKI) in critically ill adult CCU patients(2) To evaluate outcomes, including Major Adverse Kidney Events (MAKE-30 & MAKE-90), at 30- & 90-day post-discharge in critically ill adult patients with AKI)
研究者
Dr Y Srikanth Reddy
Jawaharlal Institute of Postgraduate Medical Education & Research