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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-05

Study Completion Date

2018-07-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Cardiac Disease High Risk Sex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional group:MAP declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.

Control group：no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and 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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Patients were followed up by an investigator unaware of the patients' achievement or not of the oxygen dynamic goal

Study Groups

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Individualized Goal-Directed Therapy

The goal of intervention:mean artery pressure declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline.

Group Type EXPERIMENTAL

mean artery pressure

Intervention Type PROCEDURE

mean artery pressure declined with less than 20% of baseline

bispectral index

Intervention Type PROCEDURE

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

Brain oxygen saturation

Intervention Type PROCEDURE

Brain oxygen saturation declined with less than 20% of baseline

Controlled

no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and 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.

Group Type SHAM_COMPARATOR

Controlled

Intervention Type OTHER

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.

Interventions

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mean artery pressure

mean artery pressure declined with less than 20% of baseline

Intervention Type PROCEDURE

bispectral index

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

Intervention Type PROCEDURE

Brain oxygen saturation

Brain oxygen saturation declined with less than 20% of baseline

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Other Intervention Names

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BIS

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent;
2. Selective cardiac surgery and general anesthesia patients;
3. Age 18-90 yrs;
4. Anesthesia Society of American (ASA) Scale II-IV
5. European System for Cardiac Operative Risk Evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50%

Exclusion Criteria

1. Preoperative cardiac ejection fraction\<30 %;
2. History of anesthesia awareness;
3. History or anticipation of difficult intubation;
4. Unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia;
5. long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No