Safety and Effectiveness of 4% Tetrasodium Ethylenediaminetetraacetic Acid Catheter Lock Solution in Preventing Central Venous Catheter Occlusions in Children With Intestinal Failure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 16
- 主要终点
- Incidence of catheter occlusions
研究概览
简要总结
A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).
详细描述
A total of 124 (62 per arm) will be enrolled into the study. Screening and informed consent (and assent if applicable) will be obtained prior to study procedures. The baseline assessment will be completed at recruitment to the study. Once the baseline assessment is complete and eligible subjects are randomized, the study drug will be dispensed per protocol. The study follow-up period will be 52 weeks. Four follow-up clinical in-person visits will occur at 2,12, 28, 40 and 52 weeks. Visits will be conducted by physicians or nurse practitioners. The study visits will assess general status, study bloodwork, adverse events, catheter patency, alteplase use, infection assessment, catheter integrity, and provide investigational product. Telephone follow up will occur on day-3 of intervention, and once per 4 weeks, as well as in the event of outpatient care/hospital admission, or safety event. Subject daily diaries will be utilized for detailed monitoring. Diary recordings will include adverse events, including occlusive events, and any subject specific details (e.g. dwell times, heparin flushing vs. aspiration) or issues in the delivery of the study locking solutions.
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
- None
入排标准
- 年龄范围
- 4 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients managed by the intestinal rehabilitation program at one of the participating centers.
- •Diagnosis of intestinal failure defined as need for PN support for >60 days in previous 74 days for primary intestinal disease (short bowel syndrome, primary motility disorder, mucosal enteropathy).
- •Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment.
- •Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater.
- •Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management
- •Presence of a tunneled central venous catheter (CVC), port-a-catheter, or peripherally inserted central catheter (PICC).
- •Clinical stability for at least 4 weeks and no acute medical comorbidities.
- •A minimum dwell time of 4 consecutive hours daily.
- •Care provider willing to provide informed consent to participate in the trial and willing to comply with randomization and study protocol.
排除标准
- •A temporary CVC (jugular or femoral) or peripheral catheter.
- •Patients receiving long-term PN, but not due to a primary intestinal disorder (i.e., oncology patients or premature neonates on PN due to intestinal immaturity).
- •Known hypersensitivity, allergy, or reaction to EDTA.
- •Pregnancy or nursing mother.
- •Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of the trial).
- •Severe coagulopathy (platelets <50,000, or INR > 1.5).
- •Diagnosis of immunodeficiency disorder.
- •Unstable medical condition requiring hospital admission
- •Received antibiotic therapy for CLABSI within last 14 days.
研究组 & 干预措施
KiteLock 4% Sterile Catheter Lock Solution
4% Tetrasodium EDTA lock solution (KiteLock 4% Sterile Catheter Lock Solution; SterileCare Inc., Canada) will be administered 4-24 hours daily while the patient is cycled off their PN, as per site standard operating procedures.
干预措施: KiteLock 4% Sterile Catheter Lock Solution (Device)
Heparin Lock Solution
Heparin lock solution will be administered daily per investigator judgement, given its significant clinical risk in the youngest/smallest/vulnerable subjects.
干预措施: Heparin Lock Solution (Device)
结局指标
主要结局
Incidence of catheter occlusions
时间窗: 52 weeks
Occlusion is defined as requiring chemical or surgical intervention to restore patency. Occlusion rates will be pooled for each study arm and reported per 1000 catheter days.
次要结局
- Incidence of breakage, removal, or reinsertion of catheter(52 weeks)
- Incidence of central venous thrombosis(52 weeks)
- Incidence of lock-related Serious Adverse Events (SAEs)(52 weeks)
- Incidence of Central Line-Associated Blood Stream Infections (CLABSI)(52 weeks)
- Proportion of subjects with development of Intestinal failure-associated liver disease (IFALD)(52 weeks)