MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Patient Symptoms
研究概览
简要总结
This proposal will measure the effects of mannitol administration versus placebo in hypotensive-prone, adult, maintenance hemodialysis patients with respect to changes in patient symptoms and blood pressure stability.
详细描述
A randomized crossover trial of hypertonic mannitol vs. placebo in IDH-prone participants will be performed over a 4-week period to determine the effect on:
- Patient symptoms
- The magnitude of intra-dialytic hypotension
The hypothesis to be tested is that the use of hypertonic mannitol will result in fewer adverse symptoms and less decline in intra-dialytic BP, compared with the use of placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Maintenance HD (>90 days)
- •Thrice-weekly HD
- •IDH-prone (defined as nadir intra-dialytic SBP <100 mmHg in ≥30% of sessions in the prior 4 weeks)
- •Hematocrit>21%
- •Written informed consent
排除标准
- •Acute myocardial infarction or stroke within one month
- •Pre-HD serum potassium >6.5 mmol/L in last 4 weeks
- •Pregnancy
- •Institutionalized individuals
- •Life expectancy <2 months
- •Planned renal transplant within 2 months
- •Active enrollment in another interventional trial
- •Known allergy to mannitol
研究组 & 干预措施
Mannitol
intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis
干预措施: Mannitol (Drug)
Placebo
0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis
干预措施: 0.9% saline (Drug)
结局指标
主要结局
Patient Symptoms
时间窗: 4 weeks
Comparison of average patient symptom score during mannitol arm using dialysis symptom index compared with the average score during the placebo arm (scale 0-150; higher scores worse)
次要结局
- Patient Symptoms(4 weeks)
- Intra-dialytic hypotension(4 weeks)
研究者
Finnian McCausland
Associate Physician
Brigham and Women's Hospital