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The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery

NCT03103633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2019-03-25

No results posted yet for this study

Summary

Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational study suggested that the cumulative duration of a triple-low state \[intraoperative low mean arterial pressure (MAP), low bispectral index (BIS), and low target effect-site concentration(Ce) \]was associated with poorer 30-day mortality.This randomized, prospective study based on individualized Oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (CPB).

Conditions

  • Cardiac Disease
  • High Risk Sex

Interventions

PROCEDURE

mean artery pressure

mean artery pressure declined with less than 20% of baseline

PROCEDURE

bispectral index

BIS 45-60 before and after CPB; and BIS 40-45 during CPB

PROCEDURE

Brain oxygen saturation

Brain oxygen saturation declined with less than 20% of baseline

OTHER

Controlled

receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-05
Primary Completion
2018-06-30
Completion
2018-07-30

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 NCT03103633 on ClinicalTrials.gov