NCT01777178

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 30, 2019

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

January 24, 2013

Last Update Submit

April 26, 2019

Conditions

Chronic Kidney DiseaseMetabolic Acidosis

Keywords

bicarbonatedialysis

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Low bicarbonate dialysis

EXPERIMENTAL
Other: Low bicarbonate dialysis

Interventions

Low bicarbonate dialysisOTHER
Low bicarbonate dialysis

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center/Jack D. Weiler Hospital

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, 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 K Abramowitz, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

January 24, 2013

First Posted

January 28, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 30, 2019

Record last verified: 2013-06

Locations

US(1)