Clinical trial NCT04896736: Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery
Official title: Multisite Tissue Oxygenation Guided Perioperative Care to Reduce Composite Complications in Cardiac Surgical Patients: the BOTTOMLINE-CS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Ischemia Hypoxia
Muscle; Ischemic
Muscle Hypoxia
Keywords: Cerebral Tissue Oxygen Saturation
Muscular Tissue Oxygen Saturation
Cardiac Surgery
Complications
Multisite Tissue Oxygenation Monitoring
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Tianjin Chest Hospital
First posted: 2021-05-21
Enrollment: 1960
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: from the day of surgery until postoperative day 30
measure: Postoperative delirium
timeFrame: from postoperative day 1 throughout postoperative day 5
measure: Postoperative cognitive decline
timeFrame: Assessed before surgery, on postoperative day 5 and 30
measure: Length of hospital stay
timeFrame: from the day of surgery (day 0) until hospital discharge or until day 30, whichever occurs first
measure: Perioperative stroke
timeFrame: Stroke will be assessed from the day of surgery throughout postoperative day 30
measure: Cardiac complications (one component of the primary outcome)
timeFrame: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days
measure: Respiratory failure (one component of the primary outcome)
timeFrame: from the day of surgery (i.e., day 0) until postoperative day 30 for a total of 31 days
measure: Renal complications (one component of the primary outcome)
timeFrame: from the postoperative day 1 until postoperative day 7 for a total of 7 days
measure: Infectious complications (one component of the primary outcome)
timeFrame: from postoperative day 1 until postoperative day 30 for a total of 30 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Chest Hospital
name: Jiange Han
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li G, Tian DD, Wang X, Feng X, Zhang W, Bao J, Wang DX, Ai YQ, Liu Y, Zhang M, Xu M, Mu DL, Zhao X, Dai F, Yang JJ, Che X, Yanez D, Guo X, Meng L; iMODIPONV Research Group. Muscular Tissue Oxygen Saturation and Posthysterectomy Nausea and Vomiting: The iMODIPONV Randomized Controlled Trial. Anesthesiology. 2020 Aug;133(2):318-331. doi: 10.1097/ALN.0000000000003305.