Comparison of High Versus Low Bicarbonate Hemodialysis | NCT02098356

Studies
Comparison of High Versus Low Bicarbonate Hemodialysis

NCT02098356

Sponsor

Albert Einstein College of Medicine

Status

Completed

Last Update Posted

Jul 5, 2019Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Chronic Kidney Disease
End-stage Renal Disease
Metabolic Acidosis

Interventions

Low Bicarbonate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2016Actual

First Submitted Date

Mar 24, 2014

First Submission Date that Met QC Criteria

Mar 25, 2014

First Posted Date

Mar 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2019

Last Update Posted Date

Jul 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew Abramowitz, Assistant Professor, Albert Einstein College of MedicinePrincipal Investigator

Lead Sponsor

Albert Einstein College of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

This study will compare hemodialysis treatment with a standard, high-bicarbonate dialysis bath versus a lower bicarbonate dialysis bath, and will compare intradialytic acid-base changes and overall control of metabolic acidosis with the 2 treatment regimens. These parameters will be assessed in patients currently receiving high-bicarbonate hemodialysis as part of usual care. They will then be switched to a lower bicarbonate prescription, after which these parameters will be reassessed. The study will also examine changes in inflammatory markers, glycemic control, ketogenesis, and lipolysis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low bicarbonate	Experimental	Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate	Other: Low Bicarbonate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low Bicarbonate	Other	Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate	Low bicarbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre-dialysis serum bicarbonate	Change in predialysis bicarbonate	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
serum beta-hydroxybutyrate	Change in beta-hydroxybutyrate during dialysis	5 weeks
beta-hydroxybutyrate clearance	Change in clearance between different dialysates

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18
Receiving chronic thrice-weekly conventional hemodialysis for at least 6 months

Exclusion Criteria:

Use of oral alkali within the previous month
Hospitalization within the previous month
Inability to provide written informed consent
Plans for kidney transplant in the next 2 months
Planned change in phosphate binder therapy within the next month
Pregnancy, or planned pregnancy in the next 2 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Abramowitz, MD, MS	Albert Einstein College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albert Einstein College of Medicine		The Bronx	New York	10461	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	May 2, 2014	Apr 26, 2019	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic
D000138	Acidosis

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided