NCT00776191终止4 期
Randomized, Multicenter Cross-over Study in Investigating the Effect of Bicarbonate-based Solutions (Physioneal 35 vs. 40) on Protein Metabolism in Children and Adolescents on Chronic Peritoneal Dialysis
University of Erlangen-Nürnberg Medical School5 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- To demonstrate an increase in protein metabolism during treatment with Physioneal 35® compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.
研究概览
简要总结
The purpose of this study is to demonstrate an increase in protein metabolism during treatment with Physioneal 35® (containing lactate 10 mmol/l, calcium 1.75 mmol/l) compared to treatment with Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children and adolescents with end stage renal failure receiving peritoneal dialysis.
详细描述
- Fat oxidation (13C-enrichment in expiration breath samples for U-C13-algae turnover)
- Growth markers (plasma levels of IgF-1, IgF-BP3, leptin)
- Biochemical markers of anabolism (plasma levels of total protein, albumin, transferrin)
- Serum thyroid function (fT3, fT4, TSH)
- Serum lipid status
- Serum markers of calcium/phosphate metabolism (PTH, calcium, ionized calcium, phosphate, alkaline phosphatase)
- Prevalence of metabolic acidosis/ alkalosis (venous sample), serum lactate
- Safety parameters (such as normalized weekly Kt/v, parameters of glucose metabolism, parameters of hepatic function, parameters of calcium-phosphate-metabolism, physical examination incl. standing height, weight, assessment of complications related to peritoneal dialysis as peritonitis, exit infections and inguinal hernia)
- Body composition (lean body mass and body fat mass/fluid)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are males or non-pregnant females between the ages of 3 months and 18 years.
- •Patients who are on regular automated peritoneal dialysis due to end stage renal failure for at least 3 months.
- •Patients and/or their parents must be capable of understanding the purpose and risks of the study.
- •Patients and/or their parents (or guardians) who are willing to give written informed consent and willing to participate in and comply with the study protocol.
排除标准
- •Use of pure lactate, amino acid or oligosaccharide solutions for peritoneal dialysis
- •Peritonitis episode less than 6 weeks before enrolment
- •Hypercalcemia (serum) > 2.75 mmol/l in three independent measurements during 10 days
- •Severe secondary hyperthyroidism (iPTH > 500 ng/l)
- •Renal anemia with hemoglobin (blood) < 10 mg/dl
- •Impaired hepatic function (AST/SGOT or ALT/SGPT > 2 times the upper limit of the reference range)
- •Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
- •Pregnant female patients, females of childbearing potential who are unwilling or unable to use adequate contraception methods.
- •Severe respiratory insufficiency
- •Malnourishment (body weight < -2.5 SDS for height and gender) or severe deterioration of fat metabolism
- •Patients with a history of malignancy of any organ system, treated or untreated
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the investigational product and the comparator, including
- •Major deterioration of the abdominal wall (e.g. dermal infections or burns, hernia)
- •Major deterioration of the abdominal cavity (e.g. ascites, ileus, adhesions, bowel perforation, defects of the diaphragm, tumours)
- •Patients with a history of viral infections such as HIV or hepatitis B, C.
研究组 & 干预措施
Physioneal 35 vs. 40
Active Comparator
Physioneal 35® Glucose solution with Bicarbonate 25 mmol/l, Lactate 10 mmol/l, and Calcium 1.75 mmol/l for eight weeks, followed by Physioneal 40® Glucose solution Bicarbonate 25 mmol/l, Lactate 15 mmol/l, and Calcium 1.25 mmol/l for eight weeks.
干预措施: Physioneal 35 (Drug)
Physioneal 40 vs. 35
Active Comparator
Physioneal 40® Glucose solution Bicarbonate 25 mmol/l, Lactate 15 mmol/l, and Calcium 1.25 mmol/l for eight weeks followed by Physioneal 35® Glucose solution with Bicarbonate 25 mmol/l, Lactate 10 mmol/l, and Calcium 1.75 mmol/l for eight weeks
干预措施: Physioneal 40 (Drug)
结局指标
主要结局
To demonstrate an increase in protein metabolism during treatment with Physioneal 35® compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.
时间窗: 16 weeks
次要结局
- To demonstrate a improved Fat oxidation during treatment with Physioneal compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.(16 weeks)
研究者
研究点 (5)
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