Brain Ischemia Hypoxia Clinical Trial
Official title:
Multisite Tissue Oxygenation Guided Perioperative Care to Reduce Composite Complications in Cardiac Surgical Patients: the BOTTOMLINE-CS Trial
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.
Short title: BOTTOMLINE-CS trial Methodology: International, open, single-center, pragmatic, randomised controlled trial Research sites: Tianjin Chest Hospital Objectives: 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 Number of patients: 1960 patients (980 per arm, two arms) Inclusion criteria: Patients aged ≥ 60 years undergoing elective off-pump coronary artery bypass grafting Exclusion criteria: Patient refusal, clinician refusal, preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (>10 L/min)), preoperative requirement of external cardiac assist devices, emergent or urgent surgery, patients expected to die within 30 days, current participation in another clinical trial Statistical analysis: Analyses will be performed on a modified intention-to-treat basis including all randomized patients who had undergone the scheduled surgery and had the record of the primary outcome. Summary statistics for each group, treatment effects, 95% confidence intervals, and p values will be presented for primary and secondary outcomes, and process measures. The primary outcome is a composite of complications arising within 30 days from randomization and will be analyzed using a logistic regression model. Proposed start date: May 1, 2021 (First patient to be recruited) Proposed end date: April 30, 2023 (Last patient to be recruited) Study duration: 48 months (Starting from the first patient recruitment, spanning patient recruitment, data analysis, and manuscript writing and submission) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03549520 -
CEUS Evaluation of Hypoxic Ischemic Injury
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Phase 3 |