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Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery

NCT04896736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1960

Last updated 2024-03-25

No results posted yet for this study

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

Interventions

OTHER

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

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.

Sponsors & Collaborators

  • Tianjin Chest Hospital

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Jiange Han · Tianjin Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2024-02-02
Completion
2024-02-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04896736 on ClinicalTrials.gov