OPTI-DO2: Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05984563

Collaborator

(none)

Enrollment

8.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Device: Cardiopulmonary bypass

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Official Title Optimization Strategy to Predict and Individualize Oxygen Delivery During Cardiac Surgery Under Cardiopulmonary Bypass

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 24, 2024

Anticipated Study Completion Date :

Apr 4, 2024

Outcome Measures

Primary Outcome Measures

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) [Every 20 to 30 seconds during CPB (standard care) and up to 28 days]

Secondary Outcome Measures

Incidence of postoperative AKI using creatinine measurement (standard care) [up to 48 hours postoperative]
Incidence of postoperative deliriumassessed by CAM-ICU, CPC and mRS scores [up to 48 hours postoperative]
Vital status checklist [up to 28 days postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Lille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT05984563

Other Study ID Numbers:

2022_0705

First Posted:

Aug 9, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

Oxygen delivery

Cardiopulmonary bypass

Cardiac surgery

Goal-directed perfusion

Acute kidney injury

Study Results

No Results Posted as of Aug 14, 2023