Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis.
Am J Kidney Dis
; 77(6): 920-930.e1, 2021 06.
Article
em En
| MEDLINE
| ID: mdl-33279558
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. STUDYDESIGN:
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:
Primaryoutcome:
Hierarchical composite outcome of all-cause mortality and all-cause hospitalization. Main secondaryoutcomes:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fosfatos
/
Diálise Renal
/
Hiperfosfatemia
/
Falência Renal Crônica
Tipo de estudo:
Clinical_trials
/
Guideline
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Am J Kidney Dis
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Nova Caledônia