NCT00556491已完成不适用
Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery
Tarek M. El-Achkar2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Development of Post-operative Acute Kidney Injury
研究概览
简要总结
This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •planned CABG or valvular surgery with cardiopulmonary bypass
- •Serum creatinine available (within 30 days)
- •Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4)
排除标准
- •Emergent or urgent surgery (to be performed within the next 36 hours)
- •End stage renal disease, or GFR < 15ml/min (CKD stage 5)
- •Estimated GFR>90ml/min (CKD stage 1 or no CKD)
- •Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR
- •Allergy to minocycline or tetracyclines
- •inability to take oral medications
- •use of preoperative vasopressor agents at therapeutic doses
- •Pregnant or lactating females
- •Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice)
- •Rising creatinine meeting the definition of acute kidney injury prior to surgery
- •Neurologic signs or symptoms or history of increased intracranial pressure
- •current participation in another research study involving an investigational drug or device
研究组 & 干预措施
minocycline
Active Comparator
干预措施: minocycline (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Development of Post-operative Acute Kidney Injury
时间窗: up to 5 days post cardiac surgery
Participants who develop a Creatinine increase by 0.3 mg/dl (AKIN definition) in any 48 hours time period, within 5 days post-operatively
次要结局
- Post Operative Hospital Days(30 days post-operative)
- On Vent >48 Hours(30 days post op)
- Infections Post Operative(30 days post operative)
- Stroke Post Operative(30 days post op)
- Re-operation(30 days post-operative)
研究者
Tarek M. El-Achkar
Associate Professor
St. Louis University
研究点 (2)
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