Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896736
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2021-04-26
Brief Title:
Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Multisite Tissue Oxygenation Guided Perioperative Care to Reduce Composite Complications in Cardiac Surgical Patients the BOTTOMLINE-CS Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOTTOMLINECS
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 Lmin 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000 | OTHER | CTGTY | None |