Impact of NaHCO3- on Exercise Hyperpnea

February 15, 2017 updated by: Dennis Jensen, Ph.D., McGill University

Effect of Induced Metabolic Alkalosis by Sodium Bicarbonate Administration on the Ventilatory Response to Exercise in Healthy Adults

An abnormally high V̇E/V̇CO2 response to exercise is a key pathophysiological feature of patients with chronic cardiopulmonary disease that is associated with adverse health outcomes. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to exercise has the potential to improve clinical and/or patient-reported outcomes. The investigators of this trial will compare the effects of orally administered sodium chloride (4 g, placebo) and sodium bicarbonate (0.3 g/kg of body mass) on ventilation, breathing pattern, dynamic operating lung volume, gas exhange, cardiovascular, metabolic and symptom parameters during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy adults aged 20-40 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The ventilatory response (V̇E) to exercise-induced increases in the rate of CO2 production (V̇CO2) depends on the regulated level of arterial PCO2 (PaCO2) and the dead space to tidal volume ratio (VD/VT).

An abnormally high V̇E/V̇CO2 response to exercise, reflecting a high VD/VT and/or low PaCO2 equilibrium point, is a key pathophysiological feature of patients with chronic cardiopulmonary disease, including heart failure, pulmonary arterial hypertension, interstitial lung disease and chronic obstructive pulmonary disease. In these patient groups, exercise ventilatory inefficiency is associated with: disease severity and progression; exercise intolerance; exertional breathlessness; and increased risk of hospitalization, major cardiac events and mortality. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to exercise has the potential to improve clinical and/or patient-reported outcomes. Unfortunately, our ability to enhance exercise ventilatory efficiency is limited by the fact that, with the possible exception of lung volume reduction surgery in chronic obstructive pulmonary disease and pulmonary vasodilator therapy in pulmonary arterial hypertension and heart failure, ventilation-perfusion abnormalities reflecting a high VD/VT are often irreversible.

A largely unexplored approach to decreasing the V̇E/V̇CO2 response to exercise is increasing the PaCO2 equilibrium point by inducing a metabolic alkalosis via administration of an alkalizing agent such as sodium bicarbonate (NaHCO3). Thus, the primary objective of this randomized, double blind, placebo controlled, crossover study was to test the hypothesis that increasing the PaCO2 equilibrium point via induced acute metabolic alkalosis by single-dose oral administration of NaHCO3 would decrease in the V̇E/V̇CO2 ratio at its lowest point ("nadir") during high-intensity constant-load cycle exercise testing in healthy adults.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S4
        • McGill University, Department of Kinesiology & Physical Education, Clinical Exercise & Respiratory Physiology Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Non-smoking
  • Habitually active
  • Non-obese (Body Mass Index <30 kg/m2)
  • Normal lung function on spirometry

Exclusion Criteria:

  • Self-reported gastrointestinal, cardiovascular, vascular, respiratory, kidney, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
  • Taking doctor prescribed medications other than oral contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sodium Bicarbonate
Ingestion of sodium bicarbonate (0.3 g/kg of body mass)
Drug: Sodium Bicarbonate
PLACEBO_COMPARATOR: Sodium Chloride
Ingestion of sodium chloride (4 g)
Drug: Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ventilatory equivalent to carbon dioxide (V̇E/V̇CO2) at its lowest point ("nadir") during exercise
Time Frame: Participants will be followed until all study visits are complete, an expected average of 3 weeks
The V̇E/V̇CO2 nadir will be identified as the lowest 30-sec average data point during constant-load cycle exercise testing
Participants will be followed until all study visits are complete, an expected average of 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Partial pressure of carbon dioxide in the arterialized capillary blood (PacCO2)
Time Frame: Time Frame: Participants will be followed until all study visits are complete, an expected average of 3 weeks
PacCO2 (mmHg) will be measured at rest 90-min post-dose
Time Frame: Participants will be followed until all study visits are complete, an expected average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A02-M19-15B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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