Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum concentrations of TNF-a, IL-6 and CRP
研究概览
简要总结
The aim of this study was to compare the dual use of telmisartan and captopril vs the individual use of such drugs and placebo on the systemic inflammation of patients on hemodialysis (HD).
详细描述
Once included, patients will be randomly allocated (by a computer-generated randomization list) to one of the following groups: group 1 will receive Captopril, group 2 Telmisartan, group 3 Captopril plus Telmisartan, and group 4 Placebo. Drugs will be provided as tablets during a period of 3 months. All patients will have 3 HD sessions per week, with the same kind of single-use dialysis membrane and dialysate Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 1 and 3 months, tumor necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) concentrations will be measured by ELISA using high sensitivity kits. Additionally, in the same serum samples, C-reactive protein (CRP) concentrations will be measured by nephelometry using high sensitivity kits. All laboratory measurements, including inflammation markers, will be performed in the Central Laboratory (Hospital de Especialidades, Centro Médico Nacional de Occidente), by the same personnel blinded to patient's details.
Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •≥2 months on hemodialysis
- •Arteriovenous fistula as vascular access
- •Endorsement of informed consent
排除标准
- •Inflammatory cause of ESRD
- •Liver disease, cancer, AIDS
- •Any infectious disease 2 months before the study
- •Failed kidney graft
- •Hypersensitivity to angiotensin converting enzyme inhibitors or angiotensin receptor blockers
- •Arterial hypotension
- •Pregnancy
- •Treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins, ACE inhibitors or ARB 3 months previous to the study
研究组 & 干预措施
Placebo
2 tablets of placebo orally twice a day
干预措施: Placebo (Drug)
Telmisartan plus Captopril
captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day)
干预措施: Telmisartan plus Captopril (Drug)
Telmisartan plus Placebo
telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day
干预措施: telmisartan plus placebo (Drug)
Captopril plus Placebo
patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day
干预措施: captopril plus placebo (Drug)
结局指标
主要结局
Serum concentrations of TNF-a, IL-6 and CRP
时间窗: 3 months
次要结局
未报告次要终点
研究者
Alfonso Martín Cueto Manzano
Head, Medical Research Unit of Renal Diseases
Coordinación de Investigación en Salud, Mexico
