A Prospective Evaluation of long-term outcomes and survival after Acute Kidney Injury- the AKI-LOS study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- New onset CKD is defined as (eGFR less than 60 mL/min/1.73 m2, as assessed by the CKD-EPI formula or a random urine protein to-creatinine ratio more than 150 mg/g.
研究概览
简要总结
Acute Kidney Injury (AKI) affects approximately 13.3 million people globally each year, with a higher prevalence in low- and middle-income countries (LMICs). Despite evidence linking AKI to chronic kidney disease and long-term adverse outcomes, most studies focus on high-income countries. Limited data exist on post-AKI recovery, patient-reported outcomes, and follow-up care in LMICs, particularly India. This study aims to fill this knowledge gap by evaluating the long-term consequences of AKI, risk factors for CKD, and barriers to post-discharge care among AKI survivors. The Primary Objective is to estimate the incidence of new-onset CKD in AKI survivors. The Secondary Objectives are: To analyse cardiovascular and all-cause mortality rates among AKI survivors, to study new-onset hypertension, recurrent AKI, and hospitalization rates post-AKI. To assess AKI knowledge and awareness using a validated questionnaire among AKI survivors and to identify barriers to post-discharge AKI care through qualitative interviews. Study Design: Prospective cohort study at Kasturba Hospital, Manipal. Population: Adults (greater than or equal to eighteen years) with AKI (Stage II/III) surviving hospitalization. Sample Size: Six hundred and forty patients. The Baseline data such as: Demographics, clinical history, AKI severity, laboratory markers will be collected. Follow-ups: three-months and annually, assessing kidney function, hypertension, hospitalizations, and mortality. Qualitative Study: In-depth interviews with approximately thirty AKI survivors to explore barriers to care. Statistical Analysis: Logistic regression models and subgroup analyses. Expected Outcomes & Significance of the study includes Identification of CKD risk factors post-AKI to improve early intervention, Increased awareness of AKI’s long-term effects to guide follow-up care. Insights into patient experiences and healthcare gaps to inform policy changes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients with AKI (Stage II and Stage III) who are 18 years of age or older (according to the KDIGO creatinine criteria from 2012) who are discharged alive after hospitalization for an acute/chronic illness will be included (irrespective of degree of recovery from AKI at discharge).
排除标准
- •Patients with transient AKI (AKI that resolves within 48 hours of onset, as defined by KDIGO), known Chronic kidney disease (CKD) that already existed (or imaging suggestive of CKD), those with previous history of AKI (defined as one or more episodes of AKI known to have occurred in the past five years), those with acute glomerulonephritis, kidney transplant recipients and those who do not consent for participation and subsequent follow-up will be excluded.
结局指标
主要结局
New onset CKD is defined as (eGFR less than 60 mL/min/1.73 m2, as assessed by the CKD-EPI formula or a random urine protein to-creatinine ratio more than 150 mg/g.
时间窗: At baseline,12 months and 24 months
次要结局
- 1. To analyse cardiovascular & all-cause mortality rates & risk factors among AKI survivors.(2. To assess the knowledge of AKI in survivors of an AKI episode using a validated questionnaire.)
研究者
Shayoli Sarkar
Department of Nephrology