Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery

NCT04896736 | Completed DMC

• 2 other identifiers: 2021KY-008-01000
• Study Type: interventional
• Target: 1,960
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Ischemia Hypoxia; Muscle; Ischemic; Muscle Hypoxia

Keywords

Cerebral Tissue Oxygen Saturation; Muscular Tissue Oxygen Saturation; Cardiac Surgery; Complications; Multisite Tissue Oxygenation Monitoring

Outcome Measures

Primary Outcomes (1)

• Composite complication

  The primary outcome is a collapsed (one or more) composite of the following complications with a Clavien-Dindo grade II or greater arising within 30 days of randomization (randomization and surgery are performed on the same day). The patient is regarded as having the event of composite complications if any of the following complications occur (i.e., yes); otherwise, the patient is regarded as not having the event of composite complications. The percentage of patients having the event of composite complications will be used in the primary analysis. * Brain complications (delirium, cognition decline, stroke); * Cardiac complications (non-fatal cardiac arrest, myocardial injury, heart failure, new-onset symptomatic ventricular arrhythmia); * Respiratory failure; * Renal complications (AKI stages II and III); * Infectious complications; * Death.

  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 (9)

• Atrial fibrillation

  from the day of surgery until postoperative day 30

• Postoperative delirium

  from postoperative day 1 throughout postoperative day 5

• Postoperative cognitive decline

  Assessed before surgery, on postoperative day 5 and 30

• Length of hospital stay

  from the day of surgery (day 0) until hospital discharge or until day 30, whichever occurs first

• Perioperative stroke

  Stroke will be assessed from the day of surgery throughout postoperative day 30

Study Arms (2)

Multisite tissue oxygenation monitoring-guided care

EXPERIMENTAL

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.

Other: Multisite tissue oxygenation-guided care

Usual care

ACTIVE COMPARATOR

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.

Other: Usual care

Interventions

Multisite tissue oxygenation-guided care 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

Multisite tissue oxygenation monitoring-guided care

Usual care 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.

Usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 60 years scheduled for elective off-pump CABG.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Tianjin Chest Hospital: collaborator

Study Sites (1)

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (2)

• 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.

  PMID: 32667155 BACKGROUND

• 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.

  PMID: 40127893 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Ischemia

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Jiange Han

  Tianjin Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 21, 2021
• Study Start: June 8, 2021
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)