Topics

HiLo: Pragmatic Trial of Higher vs Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis

2019-09-24 05:27:29 | BioPortfolio

Summary

HiLo will be a pragmatic, open-label, multicenter, cluster-randomized trial 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:

1. Feasibility of obtaining informed consent using electronic devices (e-consent)

2. Use of a single IRB of record for hundreds of dialysis facilities

3. Successful implementation of a trial-driven treatment algorithm by dietitians at the participating dialysis units

4. Harmonization of data from a large for-profit dialysis provider, a large not-for profit dialysis provider, and an academically-owned small dialysis provider

5. Effective monitoring of trial implementation using a centralized approach

Description

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:

1. To implement an electronic consent process;

2. To use of a single IRB of record to oversee hundreds of dialysis facilities;

3. To implement a trial-driven treatment algorithm by dietitians at the participating dialysis units

4. To harmonize across 2 different dialysis providers data elements obtained though clinical care;

5. To monitor safety without using individual adverse event reporting.

HiLo will cluster-randomize dialysis facilities using stratification to achieve balance across the two arms. Stratification will be by dialysis provider organization (DaVita or University of Utah) and by unit size (above or below the provider's median facility census). Within each stratum, the facilities will be randomly assigned. Once a facility is randomized, all of its individually enrolled patients will be assigned the same treatment.

Participants will be followed for up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months.

Two phosphate titration protocols will be used that have the same "look and feel" as those used in practice in an effort to sustain a mean time-averaged difference in serum phosphate between the two arms of ≥1 mg/dl:

1. Low serum phosphate target that is consistent with current standard of care: The goal is to titrate and maintain serum phosphate to <5.5 mg/dl.

2. Higher serum phosphate target that is the intervention strategy: The goal is to titrate and maintain serum phosphate to >6.5 mg/dl by setting a serum phosphate threshold >7.0 mg/dl when binders will be initiated, as has been done previously.

A mean serum phosphate of 4.8-5.2 is anticipated in the low arm and 6.5-6.8 in the high arm, as observed in two pilot clinical trials.Since serum phosphate is 4-7 mg/dl in most patients with ESRD, ≥1 mg/dl difference equates with a ≥33% difference within the modifiable range of time-averaged phosphate exposure. Specific binder choices will be relegated to the discretion of local providers based on local practice.

Study Design

Conditions

Mortality

Intervention

Hemodialysis

Status

Not yet recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-24T05:27:29-0400

Clinical Trials [699 Associated Clinical Trials listed on BioPortfolio]

The Efficacy of Hemoperfusion Combined With Hemodialysis in Improving the Survival of MHD Patients

This multi-center, open-label, randomized, parallel group study aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and...

Effect of Increased Convective Clearance by On-Line Hemodiafiltration on All Cause Mortality in Chronic Hemodialysis Patients

The purpose of this study is to compare the effect of low flux hemodialysis with online hemodiafiltration on all cause mortality and a combination of cardiovascular morbidity and mortality...

Factors Influencing Hemoglobin Variability and Its Association With Mortality in Hemodialysis Patients

The aim of the study is to investigate the factors influencing hemoglobin variability with inflammatory and nutritional parameters and its associations with all-cause mortality among hemod...

Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basi...

Survival Study in Patients Undergoing On-line Hemodiafiltration

Patients on hemodialysis will be randomly assigned (1:1) to continue on conventional hemodialysis or on-line hemodiafiltration, both three times per week. A 3 year follow-up and a sample s...

PubMed Articles [5380 Associated PubMed Articles listed on BioPortfolio]

Effects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis.

Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality.

The impact of hemodialysis on mortality and personal independence following hip fracture. A prospective matched cohort study.

To determine the cumulative 30-day and 1-year mortality as well as personal independence following hip fracture in patients on hemodialysis.

Comparison of three nutritional screening tools for predicting mortality in maintenance hemodialysis patients.

The aim of this study was to compare the effect of different nutritional screening tools on predicting the risk for mortality in patients on maintenance hemodialysis (MHD).

The effect of frequent hemodialysis on matrix metalloproteinases, their tissue inhibitors, and FGF23: Implications for blood pressure and left ventricular mass modification in the Frequent Hemodialysis Network trials.

Frequent hemodialysis modifies serum phosphorus, blood pressure, and left ventricular mass (LVM). We ascertained whether frequent hemodialysis is associated with specific changes in biomarker profile ...

Higher cholesterol level predicts cardiovascular event and inversely associates with mortality in hemodialysis patients: 10-year outcomes of the Q-Cohort Study.

The prevalence of atherosclerotic diseases is higher in hemodialysis patients. The aim of the current study was to investigate associations between cholesterol level and the incidences of cardiovascul...

Medical and Biotech [MESH] Definitions

Hospital units in which care is provided the hemodialysis patient. This includes hemodialysis centers in hospitals.

Long-term maintenance hemodialysis in the home.

The combination of hemodialysis and hemofiltration either simultaneously or sequentially. Convective transport (hemofiltration) may be better for removal of larger molecular weight substances and diffusive transport (hemodialysis) for smaller molecular weight solutes.

Solutions prepared for hemodialysis. The composition of the pre-dialysis solution may be varied in order to determine the effect of solvated metabolites on anoxia, malnutrition, acid-base balance, etc. Of principal interest are the effect of the choice of buffers (e.g., acetate or carbonate), the addition of cations (Na+, K+, Ca2+), and addition of carbohydrates (glucose).

Postnatal deaths from BIRTH to 365 days after birth in a given population. Postneonatal mortality represents deaths between 28 days and 365 days after birth (as defined by National Center for Health Statistics). Neonatal mortality represents deaths from birth to 27 days after birth.

More From BioPortfolio on "HiLo: Pragmatic Trial of Higher vs Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis"

Quick Search

Relevant Topic

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...


Searches Linking to this Trial