Niacinamide and renal recovery in community acquired AKI: feasibility study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary outcome measure will be the renal recovery at 4-month in patients having community-acquired AKI
研究概览
简要总结
Acute kidney injury (AKI) is a rising global health concern. The global incidence of AKI is increasing and could be attributed to an increase in cases of sepsis, rising comorbidities, increasing age of the population, and increased use of medications(1). The epidemiology of AKI varies depending on development status, climate and ethnicity. In developed countries, AKI is usually seen in urban intensive care units (ICU) and is associated with multiorgan failure (MODS), sepsis, and increasing age. While in developing countries, AKI in urban areas might be similar to developed countries but in rural areas, it is usually community-acquired and associated with infections, envenomation, diarrhea, and generally more common in the younger population(2, 3). Patients with AKI requiring dialysis have increased mortality and progression to end-stage renal disease (ESRD)(4). The ability to forecast renal recovery in an individual patient will help in clinical decision making and to facilitate clinical research in this field. The management of AKI targets the prevention of AKI and supportive therapy if AKI develops. The exact pathophysiological mechanism of the worsening of AKI could help in developing novel medications that can hamper the progression of AKI and thus improve the long-term outcome of AKI.
Several biomarkers and treatment modalities were investigated for early detection and treatment of AKI respectively. But till today management of AKI is supportive. New interest has been seen in the last few years in the field of NAD+ biosynthesis with impairment of its biosynthesis and rise in quinolinate in urine found in AKI patients. Urinary quinolinate /tryptophan was found to predict AKI and other adverse outcomes in animal studies and also in critically ill patients. This hypothesis has been applied in various studies to treat AKI with nicotinamide(5). Niacinamide bypasses the salvage denovo pathway and produces NAD. In this present study we are planning to study the role of vitamin B3 in renal recovery of patients having community acquired AKI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 – 70 years Diagnosis of community-acquired AKI.
排除标准
- •Pre-existing CKD with baseline CKD EPI eGFR<60ml/min/1.73m2 prior to the onset of illness.
- •High likelihood of underlying CKD as determined by treating physician based on clinical and laboratory parameters.
- •Suspected or biopsy proven glomerulonephritis as a cause of AKI.
- •Obstructive nephropathy as a cause of AKI.
- •Solid-organ or bone marrow transplant recipients.
- •High likelihood of re-hospitalization or death in the following 4 months as ascertained by treating physician.
- •Suspected or diagnosed case of decompensated chronic liver disease or AST/ ALT more than 5 times of upper limit of normal.
- •Suspected or diagnosed case of heart failure with functional class 3 or
- •Past or present diagnosis of malignancy.
结局指标
主要结局
Primary outcome measure will be the renal recovery at 4-month in patients having community-acquired AKI
时间窗: 4 month
次要结局
- Secondary outcome measures will include(a.all-cause mortality)