NCT02098356

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

March 24, 2014

Last Update Submit

July 1, 2019

Conditions

Chronic Kidney DiseaseEnd-stage Renal DiseaseMetabolic Acidosis

Keywords

hemodialysisdialysisacidosisbicarbonate

Outcome Measures

Primary Outcomes (1)

  • Pre-dialysis serum bicarbonate

    Change in predialysis bicarbonate

    5 weeks

Secondary Outcomes (6)

  • serum beta-hydroxybutyrate

    5 weeks

  • beta-hydroxybutyrate clearance

    5 weeks

  • interleukin-6

    5 weeks

  • serum free fatty acids

    5 weeks

  • Time to recover from dialysis

    5 weeks

  • +1 more secondary outcomes

Study Arms (1)

Low bicarbonate

EXPERIMENTAL

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Other: Low Bicarbonate

Interventions

Low BicarbonateOTHER

Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate

Low bicarbonate

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicAcidosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Matthew Abramowitz, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 28, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

July 5, 2019

Record last verified: 2018-04

Locations

US(1)