Impact of NaHCO3- on Exercise Hyperpnea

NCT ID: NCT03057535

Last Updated: 2017-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-09-30

Brief 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.

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.

Conditions

Pulmonary Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sodium Bicarbonate

Ingestion of sodium bicarbonate (0.3 g/kg of body mass)

Group Type: EXPERIMENTAL

Sodium Bicarbonate

Intervention Type: DRUG

Sodium Chloride

Ingestion of sodium chloride (4 g)

Group Type: PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type: DRUG

Interventions

Sodium Bicarbonate

Intervention Type: DRUG

Sodium Chloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Dennis Jensen, Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Jensen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

McGill University, Department of Kinesiology & Physical Education, Clinical Exercise & Respiratory Physiology Laboratory

Montreal, Quebec, Canada

Countries

Canada

Related Links

http://www.mcgill.ca/cerpl

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

Other Identifiers

A02-M19-15B

Identifier Type: -

Identifier Source: org_study_id