NCT00614679已完成1 期
A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Treatment success within 90 days
研究概览
简要总结
The primary objective is to investigate the ability of systemic intravenous antibiotic plus antibiotic/anti-biofilm (i.e. N-acetylcysteine) lock catheter technique in eradicating uncomplicated catheter associated bacteremia and salvaging the infected vascular catheter. Secondary objectives include duration to clearance of bacteremia, future recurrence of bacteremia, need for catheter removal and death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who have an indwelling hemodialysis catheter for 10 or more days and evidence of a catheter associated bloodstream infection as evidenced by 1)quantitative blood cultures obtained through the lumen of the catheter yield concentrations of bacterial colonies that are 5 or more fold higher than peripheral blood cultures, or 2)blood cultures obtained through the lumen of the catheter becomes positive 2 or more hours earlier than peripheral blood cultures.
排除标准
- •Patients will be excluded if 1) they are unable or unwilling to provide informed consent, 2) have evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osetoemylitis, deep seated abscesses etc 3)evidence of an exit site infection around the catheter such as a pus pocket, drainage or erythema. 4) patient is allergic to NAC or the proposed antibiotic (if patient is allergic to minocycline, tigecycline will not be used). 5) patient is pregnant or will become pregnant.
研究组 & 干预措施
1
Experimental
single arm trial of experimental catheter lock solution
干预措施: catheter lock solution consisting of N-acetylcystein, tigecycline and heparin (Drug)
结局指标
主要结局
Treatment success within 90 days
时间窗: 90 days
次要结局
- catheter salvage(90 days)
研究者
Saima Aslam
Associate Professor
University of California, San Diego
研究点 (3)
Loading locations...
相似试验
招募中
不适用
Study of antimicrobial lock therapy for catheter-related bloodstream infection in totally implantable central venous portJPRN-UMIN000014292Division of Gastrointestinal Surgery, Tohoku University Hospital30
终止
3 期
Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter InfectionsDialysis Catheter InfectionNCT01483872University of California, San Diego9
Unknown
不适用
Innovative Device for Intravenous AdministrationSafety IssuesMedical DeviceNCT04046770Escola Superior de Enfermagem de Coimbra146
已完成
不适用
Antimicrobial urinary catheter safety studySpecialty: Renal disorders, Primary sub-specialty: Renal disordersUKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureterUrological and Genital DiseasesLong-term (over 28 days) long-term urethral urinary catheter useISRCTN12606737niversity of Nottingham60
进行中（未招募）
4 期
Liraglutide Effect in Atrial FibrillationAtrial FibrillationNCT03856632University of Miami60