Comparison of Effectiveness and Complications of Heparin and Sodium Bicarbonate Catheter Lock Solutions in Non-Tunneled Hemodialysis Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 441
- 试验地点
- 2
- 主要终点
- Number of participants with catheter occlusion
研究概览
简要总结
In our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to Sodium bicarbonate. Both solutions were used but not compared head to head. Investigators aim to compare both solutions in terms of catheter lumen patency and their effect on catheter-related infections.
详细描述
The most important problem in patients with end-stage renal disease or patients with acute renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular access. In acute situations, vascular access is usually provided by non-tunneled catheters. Main problems with this temporaray vascular access is failure due to lumen thrombosis. anther major problem is catheter related infection. In some patients, there is a handicap of using heparin. In some situations, heparin is not preferred for use. In terms of the probable shortage of resources and cost-effectiveness, Investigators aimed to compare head to head the superiority and non-inferiority of each solution. Sodium bicarbonate was compared to the isotonic solution and found to be effective for a short time. The main aim of this study is to compare both classic Heparin and sodium bicarbonate in Femoral and Jugular catheters aimed for dialysis. In both arms, the maximum patency and the observed side effects will be recorded. The maximal time used will be recorded. statistical analysis will be planned to compare the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •All patients over 18 years who assign consent will be included
排除标准
- •patients less than 18 years of age
- •Patients with active arterial or venous thrombosis problems
- •Thrombocytopenic patients
- •Patients with hypercoagulable states
- •Patients with contraindications to heparin usage
研究组 & 干预措施
Sodium bicarbonate Arm
In this arm, the catheter lock solution is sodium bicarbonate
干预措施: Sodium bicarbonate (Drug)
Heparin arm
In this arm, classic heparin will be used as a reference catheter lock solution (standard lock solution)
干预措施: Heparin (Drug)
结局指标
主要结局
Number of participants with catheter occlusion
时间窗: 6 months
The number of cases early catheter
Number of patients with catheter related infection
时间窗: 6 months
any catheter related infection(exit site, lumen inection etc) will be recorded
Time to first catheter failure (day)
时间窗: 6 months
The time from first sucessful dialysis session to the last one (in days)
Total Duration of catheter usage (day)
时间窗: 6 months
some patients need only 1-2 dialysis sessions while others may need too many sessions. In some cases a total of three dialysi sessions is whithin 3-4 days while others may need that number in wider range (e.g 10-14 days). Here both number and duraion effect is evaluated
Causes of premature catheter malfunction
时间窗: 6 months
any catheter needing exchange prematurly will be be evaluated for mulfunction cause (etiher mechanical thromus or kink rtc.)
Time of catheter occlusion or failure
时间窗: 6 months
catheteres occluded by thrombi will be documented
次要结局
- Number of cases with venous thrombosis(6 months)
- Total number of dialysis sessions with active patent catheter usage(6 months)
研究者
mahmud islam
Medical Director of Nephrology clinic
Zonguldak Ataturk State Hospital