EUCTR2004-001390-26-GB进行中（未招募）1 期
A Subjective Evaluation of Inflow Pain: Comparison of Extraneal to Extraneal Physiological pH
Baxter R&D Europe SCR0 个研究点目标入组 20 人开始时间: 2005年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patients who have given written informed consent after the nature of the study has been explained.
- •2. Patients who are at least 18 years of age.
- •3. Patients who have been treated with PD with Physioneal 35 or 40 for at least 60 days and Extraneal for at least 30 days before the screening visit.
- •4. Patients who experience pain on infusion with Extraneal that, based on medical judgement, is not related to the catheter. Such pain is frequently or often associated with a ‘jet’ effect on inflow or with pain on outflow.
- •5. Patients who experience pain on infusion with Extraneal that, based on medical judgement, is not related to excessive IP volumes of dialysis fluid.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to screening visit. Peritonitis being defined as 2 out of 3 of the following criteria:
- •a) Cloudy peritoneal effluent with peritoneal white blood cell (WBC) count > 100 cells/mm3 due predominantly to neutrophils (>50%), (= 1L dialysate after = 2h dwell time).
- •b) Symptoms and signs of peritoneal inflammation (e.g. abdominal pain).
- •c) Demonstration of microorganism or yeast in the peritoneal effluent by culture or Gram’s stain.
- •2. Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.
- •3. Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
- •4. Patients who have received an investigational product within 30 days preceding the screening visit.
- •5. Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
- •6. Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.
- •7. Patients who experience persistent pain (= 60 minutes) after IP infusion of dialysis solution (infusion related pain is normally of shorter duration).
- •8. Patients who are allergic to starch-based polymers.
- •9. Patients who have glycogen storage disease.
- •10. Patients who have had abdominal surgery within 30 days preceding the screening visit (V0).
- •11. Patients who have had abdominal fistulae, tumours, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, surface or intra-abdominal cavity within 30 days preceding the screening visit (V0).
- •12. Patients who have maltose or isomaltose intolerance.
- •13. Patients who have other serious acute or active conditions that in the view of the investigator's opinion would preclude their participation in the study.
研究者
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