Clinical trial NCT05984563: Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass
Official title: Official Title Optimization Strategy to Predict and Individualize Oxygen Delivery During Cardiac Surgery Under Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Surgery
Keywords: Oxygen delivery
Cardiopulmonary bypass
Cardiac surgery
Goal-directed perfusion
Acute kidney injury
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgery under CPB at the university hospital of Lille, France

Brief summary: Cardiac surgery is a frequent procedure that can lead to serious complications, including acute kidney injury (AKI) or postoperative delirium. During the intervention, a cardiopulmonary bypass (CPB) is used to ensure tissue perfusion and oxygen delivery (DO2). The hypothesisis that an individualized strategy to optimize DO2 during CPB could decrease complications rate after cardiac surgery. Indeed, it is known that DO2 depends on CPB output, hemoglobin level and O2 tension. To this day, a DO2 threshold below 280 mL is known to be associated with postoperative AKI. From these data, a "Goal Directed Perfusion" strategy is widely used to maintain a DO2 above this threshold during CPB. But DO2 decrease in unpredictable, and the other factors influencing DO2 interindividual variability are not known. Moreover, the relation between DO2 and tissue perfusion is not well established, as DO2 requirement could differ between individuals or organs. Population approach using nonlinear mixed models is a method used to optimize drug administration with pharmacokinetics and pharmacodynamics models. Using this method, the aim of this study is to evaluate DO2 variability during CPB and develop a model to optimize GDP strategy.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18
* Patients scheduled for elective cardiac surgery under CPB at the university hospital of Lille, France
* Patients with given written consent
* Patient insured under the French social security system

Exclusion Criteria:

* Pregnant or breastfeeding
* Off pump cardiac surgery
* Lack of DO2 monitoring
* Emergency surgery (infectious endocarditis, aortic dissection, cardiac transplantation, LVAD implantation) Uncontrolled sepsis

Primary outcomes:
measure: values oF D02 calculated with the CONNECT software (LivaNova, London, United Kingdom) using CPB output and hemoglobin values (measured using Spectrum Medical M4) (standard care)
timeFrame: Every 20 to 30 seconds during CPB (standard care) and up to 28 days
Secondary outcomes:
measure: Incidence of postoperative AKI using creatinine measurement (standard care)
timeFrame: up to 48 hours postoperative
measure: Incidence of postoperative deliriumassessed by CAM-ICU, CPC and mRS scores
timeFrame: up to 48 hours postoperative
measure: Vital status checklist
timeFrame: up to 28 days postoperative
Other outcomes:
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