Ethanol Locks for the Treatment of Central Venous Line Infections
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Clearance of Central Venous Line Infection by Day 6 of Study
研究概览
简要总结
Ethanol Locks as an Adjunct Treatment for Central Venous Line Infections
Purpose To evaluate the effectiveness of a 70% ethanol lock solution when used as an adjunct therapy with antibiotics to treat central venous line infections
Study Design Randomized Controlled Trial
Study Protocol Only those patients meeting all inclusion criteria and no exclusion criteria will be eligible to participate in this study. Once identified, signed informed consent will be obtained from the patient's guardian and the patient himself/herself depending on age. Patients will be randomized into 2 groups: Group 1 - those patients who will receive ethanol lock therapy and Group 2- those patients who will receive placebo therapy in the form of a heparin lock solution.
Outcome Measures Treatment success as defined by-
- Clearance of the infection as documented by negative blood cultures on day 6 (one day after completed of lock treatment)
- Preservation of the line at 30 days post treatment (day 35 of the study), this will be documented by a chart review in CIS and telephone interview to ensure no further growth from blood cultures or infections
Treatment failure as defined by-
- Clinical worsening during treatment
- Removal of the line due to persistent infection or sepsis
- Recurrence of infection with the same pathogen within 30 days
详细描述
Ethanol Lock Technique Protocol (adapted from the Children's Hospital Los Angeles)
- Obtain a 3ml syringe made by the Baystate Pharmacy which will contain either sterile 70% ethanol solution or 10 units/ml heparin flush solution. Randomization into study groups will be performed by the pharmacy in patient blocks of 10. Treating physician and nurses will be blinded to patient group assignment. Syringes will be labeled "70% ethanol/heparin lock Study Solution"
- Cleanse Hands
- Use aseptic Technique throughout procedure
- Clean injection cap/posi-flow cap with alcohol for 30 seconds and let dry
- Unclamp the catheter and gently flush with normal saline to ensure patency of the catheter
- Instill ethanol/heparin lock into the catheter to fill volume
- Broviac Single Lumen 4.2 Fr (ID 0.7) Dose 0.8ml
- Broviac Single Lumen 6.6 Fr (ID 1mm) Dose 0.8ml
- Med-comp Single Lumen Catheter Dose 1.2ml
- Hickman Double Lumen 7 Fr Distal (ID 1mm) Dose 1.2ml
- Hickman Double Lumen 9 Fr Proximal (ID 0.7) Dose 1.2ml
- Med-comp Double Lumen 8 or 10 Fr Dose 1.2ml
- Port-a-cath- Any Port (including priming tubing) Dose 1.9ml
- Clamp the catheter
- Label the locked lumen with the provided label so that med is not flushed through the catheter
- Let ethanol dwell in catheter continuously for 4 hours
- When ethanol has dwelled for 4 hours, withdraw and discard the lock solution
- The above procedure should be repeated daily for 5 consecutive days
- The above procedure should be repeated to each lumen of the central venous catheter daily if there are multiple lumens
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6 months-23 years
- •documented central line infection with bacteria or fungus (positive blood culture)
排除标准
- •allergy or intolerance to ethanol
- •pregnant or breastfeeding
- •central line tunnel or exit site infection
研究组 & 干预措施
1
70% ethanol lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. 70% ethanol solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
干预措施: 70% ethanol (Drug)
2
heparin flush 10 units/ml lock solution instilled into central venous line of patient with documented infection, in addition to usual care with antimicrobials and supportive therapy. heparin flush solution dwells for 4 hours, then is withdrawn and discarded. This procedure repeated daily for 5 consecutive days.
干预措施: heparin flush solution (Drug)
结局指标
主要结局
Clearance of Central Venous Line Infection by Day 6 of Study
时间窗: 6 days
次要结局
- Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study(35 days)
- Recurrence of Central Venous Line Infection Within 35 Days of Enrollment(35 days)
研究者
christine mckiernan
Division Chief, Pediatric Critical Care
Baystate Medical Center