Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis

An observational study of End Stage Renal Disease, run by Samuel Silver.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this quality improvement study was to determine the effect of an institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (CKD-MBD) targets for patients on chronic hemodialysis. Read more about this study

Who is it for?: Any age
Conditions the study is for: End Stage Renal Disease
What is being tested?: Four-week routine bloodwork and Six-week routine bloodwork
How many people: 400 participants
Where: No sites listed yet
Study dates: 1 Jun 2012to 31 Dec 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patients on chronic hemodialysis at a regional hemodialysis program in Kingston, Ontario, Canada, from June 1, 2012 to December 31, 2015

Who may be able to join

all patients who received chronic hemodialysis at the Kingston Health Sciences Center regional hemodialysis program

Who cannot join

none

About this study

Read the detailed description

Rationale \& Objective: Routine bloodwork for patients on hemodialysis has both financial and opportunity costs, but there is little data on how the frequency of measurement affects patient outcomes. Our objective was to determine the effect of changing from routine bloodwork at four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (CKD-MBD) targets.

Study Design: Retrospective interrupted time series from June 1, 2012 to December 31, 2015.

Setting \& Participants: Tertiary hospital in Ontario, Canada, that provides hemodialysis to 350-400 adult patients.

Quality Improvement Activities: Institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on March 24, 2014.

Outcomes: Proportion of patients who achieved recommended hemoglobin and phosphate targets. In a 252-day sub-analysis, we also calculated the cost-savings attributable to a change in laboratory testing frequency for hemoglobin, ferritin, iron saturation, calcium, and phosphate.

Analytical Approach: Statistical Process Control to analyze variation in the clinical outcomes.

Conditions: End Stage Renal Disease
Being tested: Four-week routine bloodwork, Six-week routine bloodwork
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Four-week routine bloodworkDiagnostic test
Routine hemodialysis bloodwork done every 4 weeks
Six-week routine bloodworkDiagnostic test
Routine hemodialysis bloodwork done every 6 weeks

Study groups in NCT03659500
Study group	Role	What they receive
Four-week routine bloodwork		Routine bloodwork every 4-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from June 1, 2012 to March 23, 2014 Receives: Diagnostic Test: Four-week routine bloodwork
Six-week routine bloodwork		Routine bloodwork every 6-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from March 25, 2014 to December 31, 2015 Receives: Diagnostic Test: Six-week routine bloodwork

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin target achievement
Proportion of patients who achieved hemoglobin (10-12 g/dl)
Measured: 650 days
Phosphate target achievement
Proportion of patients who achieved phosphate (2.5-4.6 mg/dl)
Measured: 650 days

Secondary outcomes (4)

Use of erythropoietin
Proportion of patients on erythropoietin
Measured: 650 days
Calcium target achievement
Proportion of patients with calcium (8.8-10.2 mg/dl)
Measured: 650 days
PTH target achievement
Proportion of patients with PTH (94-462 pg/ml)
Measured: 650 days
All-cause mortality
All-cause mortality
Measured: 650 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201231 Dec 2015

First posted6 Sep 2018
Study start1 Jun 2012
Primary completion31 Dec 2015
Study completion31 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03659500
Sponsor's protocol ID: HD Lab Frequency 1
Status last verified: Apr 2024
First submitted: 29 Aug 2018
Last updated: 3 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Silver SA, Alaryni A, Alghamdi A, Digby G, Wald R, Iliescu E. Routine Laboratory Testing Every 4 Versus Every 6 Weeks for Patients on Maintenance Hemodialysis: A Quality Improvement Project. Am J Kidney Dis. 2019 Apr;73(4):496-503. doi: 10.1053/j.ajkd.2018.10.008. Epub 2018 Dec 28.
PubMed 30598347

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis
ClinicalTrials.gov ID: NCT03659500
Acronym / sponsor ID: HD Lab Frequency 1
Conditions: End Stage Renal Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Samuel SilverUniversity, hospital or other
Collaborators: University of Toronto
Study start: 1 Jun 2012 (actual)
Primary completion: 31 Dec 2015 (actual)
Study completion: 31 Dec 2015 (actual)
First posted: 6 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design: Retrospective interrupted time series from June 1, 2012 to December 31, 2015.

Setting \& Participants: Tertiary hospital in Ontario, Canada, that provides hemodialysis to 350-400 adult patients.

Quality Improvement Activities: Institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on March 24, 2014.

Analytical Approach: Statistical Process Control to analyze variation in the clinical outcomes.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Four-week routine bloodwork	–	Diagnostic Test: Four-week routine bloodworkRoutine bloodwork every 4-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from June 1, 2012 to March 23, 2014
Six-week routine bloodwork	–	Diagnostic Test: Six-week routine bloodworkRoutine bloodwork every 6-weeks (CBC, electrolytes, iron studies, calcium, phosphate, PTH) from March 25, 2014 to December 31, 2015

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients on chronic hemodialysis at a regional hemodialysis program in Kingston, Ontario, Canada, from June 1, 2012 to December 31, 2015

Key inclusion criteria (1 listed)

all patients who received chronic hemodialysis at the Kingston Health Sciences Center regional hemodialysis program

Key exclusion criteria (1 listed)

none

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Four-week routine bloodworkRoutine hemodialysis bloodwork done every 4 weeks	Diagnostic test	Four-week routine bloodwork
Six-week routine bloodworkRoutine hemodialysis bloodwork done every 6 weeks	Diagnostic test	Six-week routine bloodwork

Primary outcome

Hemoglobin target achievement
Time frame: 650 days
Proportion of patients who achieved hemoglobin (10-12 g/dl)
Phosphate target achievement
Time frame: 650 days
Proportion of patients who achieved phosphate (2.5-4.6 mg/dl)

4 secondary outcomes

Use of erythropoietin
Time frame: 650 days
Calcium target achievement
Time frame: 650 days
PTH target achievement
Time frame: 650 days
All-cause mortality
Time frame: 650 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Results publication: PubMed 30598347Silver SA, Alaryni A, Alghamdi A, Digby G, Wald R, Iliescu E. Routine Laboratory Testing Every 4 Versus Every 6 Weeks for Patients on Maintenance Hemodialysis: A Quality Improvement Project. Am J Kidney Dis. 2019 Apr;73(4):496-503. doi: 10.1053/j.ajkd.2018.10.008. Epub 2018 Dec 28.
Individual participant dataSharing planned: No

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samuel A Silver principal investigator

Queen's University

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Disease, run by Samuel Silver.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin target achievement (time frame: 650 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03659500, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.