Dataset Information

Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.

ABSTRACT:

Rationale & objective

Hyperphosphatemia is a risk factor for poor clinical outcomes in patients with kidney failure receiving maintenance dialysis. Opinion-based clinical practice guidelines recommend the use of phosphate binders and dietary phosphate restriction to lower serum phosphate levels toward the normal range in patients receiving maintenance dialysis, but the benefits of these approaches and the optimal serum phosphate target have not been tested in randomized trials. It is also unknown if aggressive treatment that achieves unnecessarily low serum phosphate levels worsens outcomes.

Study design

Multicenter, pragmatic, cluster-randomized clinical trial.

Setting & participants

HiLo will randomize 80-120 dialysis facilities operated by DaVita Inc and the University of Utah to enroll 4,400 patients undergoing 3-times-weekly, in-center hemodialysis.

Intervention

Phosphate binder prescriptions and dietary recommendations to achieve the "Hi" serum phosphate target (≥6.5 mg/dL) or the "Lo" serum phosphate target (<5.5 mg/dL).

Outcomes

Primary outcome: Hierarchical composite outcome of all-cause mortality and all-cause hospitalization. Main secondary outcomes: Individual components of the primary outcome.

Results

The trial is currently enrolling.

Limitations

HiLo will not adjudicate causes of hospitalizations or mortality and does not protocolize use of specific phosphate binder classes.

Conclusions

HiLo aims to address an important clinical question while more generally advancing methods for pragmatic clinical trials in nephrology by introducing multiple innovative features including stakeholder engagement in the study design, liberal eligibility criteria, use of electronic informed consent, engagement of dietitians to implement the interventions in real-world practice, leveraging electronic health records to eliminate dedicated study visits, remote monitoring of serum phosphate separation between trial arms, and use of a novel hierarchical composite outcome.

Trial registration

Registered at ClinicalTrials.gov with study number NCT04095039.

SUBMITTER: Edmonston DL

PROVIDER: S-EPMC9933919 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.

Edmonston Daniel L DL Isakova Tamara T Dember Laura M LM Brunelli Steven S Young Amy A Brosch Rebecca R Beddhu Srinivasan S Chakraborty Hrishikesh H Wolf Myles M

American journal of kidney diseases : the official journal of the National Kidney Foundation 20201203 6

<h4>Rationale & objective</h4>Hyperphosphatemia is a risk factor for poor clinical outcomes in patients with kidney failure receiving maintenance dialysis. Opinion-based clinical practice guidelines recommend the use of phosphate binders and dietary phosphate restriction to lower serum phosphate levels toward the normal range in patients receiving maintenance dialysis, but the benefits of these approaches and the optimal serum phosphate target have not been tested in randomized trials. It is als ...[more]

PMID: 33279558

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Project description:Rationale & objectiveFor older adults, maintaining mobility is a major priority, especially for those with advanced chronic diseases like kidney failure. However, our understanding of the factors affecting mobility in older adults receiving maintenance hemodialysis is limited.Study designDescriptive qualitative study.Setting & participantsUsing purposive sampling, we recruited (1) persons aged≥60 years receiving maintenance hemodialysis; and (2) care partners (≥18 years) providing regular support to an older adult receiving hemodialysis. During a single in-person home visit, we assessed mobility using the Short Physical Performance Battery (SPPB) and conducted individual one-on-one interviews regarding important personal factors related to mobility.Analytical approachDescriptive statistics were used for demographic and SPPB data. Transcripts underwent thematic coding, informed by the International Classification of Function framework of mobility. We used conceptual content analysis to inductively extract themes and subthemes.ResultsWe enrolled 31 older adults receiving hemodialysis (42% female, 68% Black) with a mean age of 73±8 years and mean dialysis vintage of 4.6±3.5 years; their mean SPPB score was 3.6±2.8 points. Among 12 care partners (75% female, 33% Black), the mean age was 54±16 years and mean SPPB score was 10.1±2.4 points. Major themes extracted were (1) mobility represents independence; (2) mobility is precarious; (3) limitations in mobility cause distress; (4) sources of encouragement and motivation are critical; and (5) adaptability is key.LimitationsModest sample from single geographic area.ConclusionsFor older adults receiving hemodialysis, mobility is severely limited and is often precarious in nature, causing distress. Older adults receiving hemodialysis and their care partners have identified sources of encouragement and motivation for mobility, and cite an adaptable mindset as important. Future studies should conceptualize mobility as a variable condition and build on this outlook of adaptability in the development of interventions.

Dataset Information

Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.

Rationale & objective

Study design

Setting & participants

Intervention

Outcomes

Results

Limitations

Conclusions

Trial registration

Publications

Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.

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