Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery

NCT ID: NCT04896736

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1960 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2024-02-02

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)

Conditions

Brain Ischemia Hypoxia; Muscle; Ischemic; Muscle Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Multisite tissue oxygenation monitoring-guided care

Details are as follows. • Monitoring: SctO2 monitored using two probes placed on left and right forehead. SstO2 monitored using one probe placed over the forearm brachioradialis muscle on the arm not used for non-invasive blood pressure monitoring.

• Baseline: The first baseline is measured 12-48 hours before surgery, with the patient supine, awake, calm, eyes closed, and breathing room air or oxygen that is equivalent to the home oxygen rate for patients using home oxygen.

• Goals: Maintain both SctO2 and SstO2 within 90-110% of the baseline level.
• Trigger of intervention: SctO2/SstO2 outside of the 90-110% baseline range.
• Diagnosis:
• Care team: The caregivers providing SctO2/SstO2-guided care will be trained and given the opportunity to use the intervention protocol in at least 20 patients before the formal study.
• Treatments: Refer to the algorithm to restore SctO2/SstO2 within 90-110% baseline range.

Group Type: EXPERIMENTAL

Multisite tissue oxygenation-guided care

Intervention Type: OTHER

The following intervention algorithm is intended to be used as a guidance only. We emphasize the different aspects that can cause changes in SctO2/SstO2 in a systematic approach. We avoid recommending a concrete drug and method of dosing for a specific condition.

Manage tissue perfusion Preload: overall picture including direct observation of the heart, findings of echocardiography, urine output, blood loss, labs results, HR, BP, PPV, SVV, fluid responsiveness (SV increase >/= 10% following 250 ml fluid bolus) Contractility: direct observation of the heart, findings of echocardiography Stroke volume and heart rate: important determinants of CO Systemic vascular resistance: important determinant of BP Regional vascular resistance: important determinant of tissue perfusion along with perfusion pressure Maintain autoregulation: normalize CO2, avoid potent vasodilators

Manage arterial blood oxygen content

Manage tissue metabolic activity

Usual care

Patients in the control group will be managed by clinical staff according to usual care. Patients in this group will be monitored using the same tissue oximeter used in the intervention group; however, the screen will be covered by an opaque cloth to prohibit the care givers seeing the monitoring data. The same baseline measurements will be performed in patients allocated to the usual care group.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care in this study means the standard perioperative care. Patients who are meant to receive usual care will receive both cerebral and muscular tissue oxygen saturation monitoring; however, the monitor screen will be covered and the monitoring data will not be used to guide clinical care.

Interventions

Multisite tissue oxygenation-guided care

The following intervention algorithm is intended to be used as a guidance only. We emphasize the different aspects that can cause changes in SctO2/SstO2 in a systematic approach. We avoid recommending a concrete drug and method of dosing for a specific condition.

Manage tissue perfusion Preload: overall picture including direct observation of the heart, findings of echocardiography, urine output, blood loss, labs results, HR, BP, PPV, SVV, fluid responsiveness (SV increase >/= 10% following 250 ml fluid bolus) Contractility: direct observation of the heart, findings of echocardiography Stroke volume and heart rate: important determinants of CO Systemic vascular resistance: important determinant of BP Regional vascular resistance: important determinant of tissue perfusion along with perfusion pressure Maintain autoregulation: normalize CO2, avoid potent vasodilators

Manage arterial blood oxygen content

Manage tissue metabolic activity

Intervention Type: OTHER

Usual care

Usual care in this study means the standard perioperative care. Patients who are meant to receive usual care will receive both cerebral and muscular tissue oxygen saturation monitoring; however, the monitor screen will be covered and the monitoring data will not be used to guide clinical care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Chest Hospital

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiange Han

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Locations

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 32667155 (View on PubMed)

Han J, Zhai W, Wu Z, Zhang Z, Wang T, Ren M, Liu Z, Sessler DI, Guo Z, Meng L; Bottomline-CS investigation group. Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial. BMJ. 2025 Mar 24;388:e082104. doi: 10.1136/bmj-2024-082104.

Reference Type: DERIVED

PMID: 40127893 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2021KY-008-01

Identifier Type: -

Identifier Source: org_study_id