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NCT05984563: OPTI-DO2
Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass
trial testing Cardiopulmonary bypass in Cardiac Surgery in 70 participants. Status unknown.
24 February 2024
Quick facts
| Lead sponsor | University Hospital, Lille |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 70 |
| Start date | 1 August 2023 |
| Primary completion | 24 February 2024 |
| Estimated completion | 4 April 2024 |
Drugs / interventions tested
- Cardiopulmonary bypass
Conditions studied
- Cardiac Surgery — all drugs for Cardiac Surgery →
Sponsor
University Hospital, Lille
Who can join
Adults 18 to 100, any sex, with Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05984563
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05984563 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Lille
- Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05984563.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing