HiLo: Pragmatic Trial of Higher vs Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 793
- 试验地点
- 168
- 主要终点
- Hierarchical Composite Mortality and All Cause Hospitalization
研究概览
简要总结
HiLo will be a pragmatic, open-label, multicenter, clinical trial with individual level randomization of ~4400 patients with ESRD undergoing in-center maintenance hemodialysis at 120-150 units maintained by two dialysis organizations that care for a substantial proportion of the US dialysis population. The 1st objective of HiLo is to test the following primary and secondary hypotheses of HiLo:
Primary hypothesis: Compared to the current standard approach of targeting serum phosphate levels of <5.5 mg/dl, less stringent control of serum phosphate to target levels of ≥6.5 mg/dl will yield a reduction in the hierarchical composite outcome of time to all-cause mortality and all-cause hospitalization among patients with ESRD undergoing hemodialysis.
Secondary hypothesis: The main secondary hypotheses are that less stringent control of serum phosphate will reduce risk of all-cause mortality as well as the risk of all-cause hospitalization (individually) compared to the current standard approach of strict phosphate control (superiority analysis). In addition, the trial will test the secondary hypotheses that less stringent control of serum phosphate will result in increased serum albumin and protein catabolic rate (PCR), as markers of diet and nutrition.
The 2nd objective of HiLo is to conduct a second-generation pragmatic clinical trial in dialysis. In partnership with two dialysis provider organizations, demonstrate the following for a trial embedded in clinical care delivery:
- Feasibility of obtaining informed consent using electronic devices (e-consent)
- Use of a single IRB of record for hundreds of dialysis facilities
- Successful implementation of a trial-driven treatment algorithm by dietitians at the participating dialysis units
- Harmonization of data from a large for-profit dialysis provider and an academically-owned small dialysis provider
- Effective monitoring of trial implementation using a centralized approach
详细描述
Pragmatic Trial Demonstration Goals
The HiLo Trial is one of the pragmatic trial demonstration projects of the NIH Health Care Systems (HCS) Research Collaboratory. These demonstration projects are intended to be large clinical trials that are conducted within the clinical care environment and evaluate interventions implemented by care providers and relying as much as possible on data obtained as part of routine clinical care. HiLo has the following demonstration project goals:
- To implement an electronic consent process;
- To use a single IRB of record to oversee hundreds of dialysis facilities;
- To implement a trial-driven treatment algorithm by dietitians at the participating dialysis units
- To harmonize across 2 different dialysis providers data elements obtained though clinical care;
- To monitor safety without using individual adverse event reporting.
HiLo will individually randomize participants using facility-level stratification to achieve balance across the two arms. Stratification will be 1:1 within each facility.
Participants will be followed for up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months.
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
- None
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
- •Adults over 18 years of age
- •Undergoing 3 times weekly in-center hemodialysis and have been receiving dialysis treatment for at least 3 months
- •Able to provide written informed consent
排除标准
- •Pregnancy
- •In-center Nocturnal
- •Calciphylaxis
结局指标
主要结局
Hierarchical Composite Mortality and All Cause Hospitalization
时间窗: up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Hierarchical composite of time to all-cause mortality and all-cause hospitalization rate (total counts per person-years of follow-up) for the individually randomized cohort
次要结局
- Time to All-cause-mortality(up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months)
- Hospitalization Days(up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months)
- Serum Albumin(Baseline (days -30 - 0))
- Protein Catabolic Rate (PCR)(Baseline (days -30 - 0))