Impact of NaHCO3- on Exercise Hyperpnea

Pulmonary Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057535
• Other study ID #: A02-M19-15B
• Status: Completed
• Phase: Early Phase 1
• First received: February 10, 2017
• Last updated: February 15, 2017
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Ventilation

Intervention

Drug:
• Sodium Bicarbonate

• Sodium Chloride

Locations

Country	Name	City	State
Canada	McGill University, Department of Kinesiology & Physical Education, Clinical Exercise & Respiratory Physiology Laboratory	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilatory equivalent to carbon dioxide (V?E/V?CO2) at its lowest point ("nadir") during exercise	The V?E/V?CO2 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	Partial pressure of carbon dioxide in the arterialized capillary blood (PacCO2)	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

External Links

•   Clinical Exercise & Respiratory Physiology Laboratory (CERPL) of McGill University