CompletedNot Applicable

Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery

China1,960 participantsStarted 2021-06-08

Plain-language summary

The BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged ≥ 60 years scheduled for elective off-pump CABG. Exclusion Criteria: * Inability or refusal to provide consent of participation * Preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (\>10 L/min)) * Preoperative requirement of external cardiac assist device * Urgent or emergent surgery * Patients expected to die within 30 days of randomization

What they're measuring

Composite complication

Timeframe: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days (individual components may vary)

Trial details

NCT IDNCT04896736

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-02

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