Efek N-Acetylcysteine Terhadap Cedera Tubulus Ginjal, Stres Oksidatif, Dan Inflamasi Pada Pasien Leptospirosis Non-Severe: Sebuah Uji Klinis Acak Tersamar Ganda
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in Urinary Kidney Injury Molecule-1 (KIM-1) Level From Day 1 to Day 5
研究概览
简要总结
The goal of this clinical trial is to learn whether oral N-acetylcysteine (NAC) can reduce markers of kidney tubular injury, oxidative stress, and inflammation in adults with non-severe leptospirosis. The main questions it aims to answer are:
- Does NAC result in a greater reduction in urinary kidney injury molecule-1 (KIM-1) levels from Day 1 to Day 5 compared with placebo?
- Does NAC result in a greater reduction in serum reactive oxygen species (ROS) and C-reactive protein (CRP) levels from Day 1 to Day 5 compared with placebo?
Researchers will compare NAC with a placebo to determine whether NAC produces greater changes in these biomarkers.
Participants will:
- Receive oral NAC 800 mg three times daily or a matching placebo for five days in addition to standard treatment for leptospirosis.
- Have urinary KIM-1, serum ROS, and CRP measured before treatment and on Day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple
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
- •Adults aged 18 years or older.
- •Fever onset on Day 3 to Day
- •Non-severe leptospirosis (mild to moderate) according to WHO classification, confirmed serologically by a positive Leptospira IgM ELISA test.
- •No history of chronic kidney disease based on medical history, medical records, or kidney function assessment before the leptospirosis episode.
- •Willing to participate in the study and provide written informed consent.
- •No previous N-acetylcysteine therapy before randomization.
排除标准
- •Severe leptospirosis or Weil's disease according to WHO classification.
- •Chronic kidney disease stage G3-G5 according to KDIGO classification.
- •Diabetes mellitus with diabetic nephropathy.
- •Uncontrolled or malignant hypertension.
- •Glomerulonephritis or other immunologic kidney disease.
- •Current use of potentially nephrotoxic medications, including aminoglycosides, non-steroidal anti-inflammatory drugs, chemotherapeutic agents, or other nephrotoxic drugs.
- •Severe chronic liver disease.
- •Severe heart disease or severe circulatory disorder.
- •Severe chronic pulmonary disease, including severe chronic obstructive pulmonary disease or uncontrolled persistent severe asthma.
- •Gastrointestinal disorders that may impair oral N-acetylcysteine absorption, including ileus, persistent vomiting, or severe malabsorption.
- •Pregnancy or breastfeeding.
- •History of hypersensitivity to N-acetylcysteine.
- •Refusal to participate or withdrawal of informed consent.
研究组 & 干预措施
Arm 2
Placebo
干预措施: Placebo (Drug)
Arm 1
N-acetylcysteine
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Change in Urinary Kidney Injury Molecule-1 (KIM-1) Level From Day 1 to Day 5
时间窗: Day 1 to Day 5
Change in urinary KIM-1 concentration from before treatment (Day 1) to Day 5, compared between the N-acetylcysteine and placebo groups.
Change in Serum Reactive Oxygen Species (ROS) Level From Day 1 to Day 5
时间窗: Day 1 to Day 5
Change in serum reactive oxygen species (ROS) concentration from before treatment (Day 1) to Day 5, compared between the N-acetylcysteine and placebo groups.
次要结局
未报告次要终点
研究者
Selfie C. Rijal
Nephrology and Hypertension Trainee, Internist, Department of Internal Medicine, Principal Investigator
Dr Cipto Mangunkusumo General Hospital