Comparison of Standard Versus Low Bicarbonate Hemodialysis | NCT01777178

Studies
Comparison of Standard Versus Low Bicarbonate Hemodialysis

NCT01777178

Sponsor

Albert Einstein College of Medicine

Status

Completed

Last Update Posted

Apr 30, 2019Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Chronic Kidney Disease
Metabolic Acidosis

Interventions

Low bicarbonate dialysis

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

Jun 2013

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

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jan 24, 2013

First Submission Date that Met QC Criteria

Jan 24, 2013

First Posted Date

Jan 28, 2013Estimated

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

Apr 26, 2019

Last Update Posted Date

Apr 30, 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

This study will compare acid-base changes during hemodialysis treatments with a standard dialysis bath versus a lower bicarbonate dialysis bath, and aims to define the factors that limit equilibration of the bicarbonate concentration in a patient's blood with that in the dialysate.

Detailed Description

Not provided

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Low bicarbonate dialysis	Experimental		Other: Low bicarbonate dialysis

Name	Type	Description	Arm Group Labels	Other Names
Low bicarbonate dialysis	Other		Low bicarbonate dialysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in beta-hydroxybutyrate clearance	Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations	1-2 weeks
Change in lactate clearance	Comparison between 2 hemodialysis treatments with different bicarbonate dialysis concentrations	1-2 weeks
Post-dialysis pH		1-2 weeks
Post-dialysis bicarbonate		1-2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Receiving chronic thrice-weekly conventional hemodialysis for at least 3 months
Age > 18 years

Exclusion Criteria:

Use of oral alkali within the previous month
Hospitalization within the previous month
Inability to provide written informed consent
Pregnancy

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 K Abramowitz, MD, MS	Albert Einstein College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montefiore Medical Center/Jack D. Weiler Hospital		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	Jan 3, 2013	Apr 26, 2019	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, 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