NCT00135863终止不适用
Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
Ribe County Hospital2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Grade of inflammation, local and systemic
研究概览
简要总结
Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease
- •Peritoneal dialysis without complication for minimum of three months
- •18 years or above
- •Informed consent
排除标准
- •Known coagulatory defects including anticoagulation therapy
- •Known bleeding tendency
- •Peritonitis within two months prior to inclusion
- •Pregnancy
- •Breast feeding
- •Active infection
- •Non-informed consent
- •Allergy to heparin or prior heparin induced thrombocytopenia
结局指标
主要结局
Grade of inflammation, local and systemic
次要结局
- Change in local cellular distribution
- Change in local and systemic generation of thrombi
- Vascular compliance
- Nutritional state
- Efficacy of Peritoneal Dialysis
研究者
研究点 (2)
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