Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02031770
Recruitment Status : Completed
First Posted : January 9, 2014
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Denver Health and Hospital Authority
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metabolic Acidosis
Chronic Kidney Disease
Interventions Drug: Sodium bicarbonate
Other: Control
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A: Treatment/Control B: Control/Treatment
Hide Arm/Group Description

Patients will start with sodium bicarbonate treatment then switch to control (no treatment)

Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.

Control: subjects will receive no treatment

Patients will start with control (no treatment) then switch to sodium bicarbonate treatment

Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.

Control: subjects will receive no treatment

Period Title: Overall Study
Started 10 10
Completed 9 9
Not Completed 1 1
Arm/Group Title Study Participants
Hide Arm/Group Description

Patients will start with sodium bicarbonate treatment then switch to control (no treatment)

Sodium bicarbonate: Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.

Control: subjects will receive no treatment

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Change in Brachial Artery Flow Mediated Dilation (FMD)
Hide Description The primary endpoint is change in brachial artery FMD between treatment and control conditions. Each treatment period is 6 weeks in duration with a 2 week washout period in between. Outcome measures will be repeated at the beginning and end of each period.
Time Frame 6 weeks and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: absolute change in percent FMD
1.1  (2.6) -0.7  (1.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/20 (55.00%)      0/20 (0.00%)    
Cardiac disorders     
Leg swelling [1]  4/20 (20.00%)  4 0/20 (0.00%)  0
Gastrointestinal disorders     
Nausea  7/20 (35.00%)  7 0/20 (0.00%)  0
[1]
lower extremity edema
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jessica Kendrick
Organization: University of Colorado Denver
Phone: 3037244837
EMail: Jessica.Kendrick@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02031770    
Other Study ID Numbers: 13-2017
First Submitted: January 7, 2014
First Posted: January 9, 2014
Results First Submitted: September 3, 2020
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020