Bicarbonate Variation Monitoring With Indirect Calorimetry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
Patients admitted to the intensive care unit frequently exhibit abnormal blood bicarbonate levels. These abnormalities are associated with patient outcomes and often prompt clinicians to modify management, either diagnostically or therapeutically (e.g., initiation or adjustment of mechanical ventilation, initiation or modification of extracorporeal renal replacement therapy, administration of specific diuretics, or sodium bicarbonate infusion).
Currently, the only way to determine blood bicarbonate concentration is through repeated blood sampling for laboratory analysis. However, this method is both discontinuous and invasive.
We have generated an in silico hypothesis suggesting that the mismatch between cellular CO₂ production/elimination and pulmonary CO₂ elimination reflects changes in blood bicarbonate levels. We propose to test this hypothesis in a cohort of intensive care unit patients.
If confirmed, indirect calorimetry could be positioned as a continuous, non-invasive monitoring tool for blood bicarbonate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient admitted to the ICU within the past 72 hours
Receiving invasive mechanical ventilation
For whom the treating clinician plans to perform at least two blood bicarbonate measurements within the next 6 hours
No objection from the participant or their next of kin
Disqualifiers
Planned weaning from invasive mechanical ventilation or ventilator change before the second bicarbonate measurement
Inspiratory oxygen fraction > 60%
Administration of inhaled medications, including nitric oxide
Positive end-expiratory pressure (PEEP) > 15 cmH₂O
Trial population
Patients admitted to the ICU
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Indirect calorimetry measurement
DeviceSetup of an indirect calorimetry monitor
Treatment groups
91 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
Correlation coefficient between the CO₂ production/elimination mismatch assessed by indirect calorimetry and the change in blood bicarbonate over the study period.
CO₂ production/elimination mismatch is estimated using the indirect calorimetry, assuming that the respiratory quotient remains constant throughout the study. Change in blood bicarbonate is obtained using two consecutive arterial blood samples. This relationship will be assessed using Pearson's correlation coefficient if assumptions are met (normality and linearity); otherwise, Spearman's coefficient will be used. The correlation coefficient will be reported with its 95% confidence interval and p-value, and the relationship will be illustrated with a scatter plot and regression line or trend curve.
Time frame
At day 1Sponsors and contacts
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Source ClinicalTrials.gov
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