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

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ClinicalTrials.gov Identifier: NCT03103633
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Anhui Medical University

Brief 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).

Condition or disease Intervention/treatment Phase
Cardiac Disease High Risk Sex Procedure: mean artery pressure Procedure: bispectral index Procedure: Brain oxygen saturation Other: Controlled Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients were followed up by an investigator unaware of the patients' achievement or not of the oxygen dynamic goal
Primary Purpose: Prevention
Official Title: Effects of Perioperative Goal-Directed Therapy Based on Individualized Oxygen Balance on Outcomes During High-risk Cardiac Surgery:A Single Center, Prospective,Randomized,Controlled,Double Blinded Study.
Actual Study Start Date : March 5, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: 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.
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
Other Name: BIS

Procedure: Brain oxygen saturation
Brain oxygen saturation declined with less than 20% of baseline

Sham Comparator: 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.
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.




Primary Outcome Measures :
  1. Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis) [ Time Frame: 30-day after surgery ]
    Number of Participants with major complications extracted after 30-day follow-up

  2. 30-day mortality [ Time Frame: 30-day after surgery ]
    Data for duration of postoperative 30-day all-cause mortality

  3. The change of incidence of postoperative delirium [ Time Frame: The 1,2,3 day after surgery ]
    Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium

  4. 1,3,5-year mortality [ Time Frame: 1,3,5-year after surgery ]
    Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up


Secondary Outcome Measures :
  1. postoperative hospital stay [ Time Frame: 30-day after surgery ]
    Data for duration of postoperative hospital stay is extracted after 30-day follow-up

  2. The change of incidence of postoperative cognition dysfunction [ Time Frame: 1 day before surgery, the 3,7 day after the surgery ]
    The neuropsychological tests performed at the day before the surgery,the 3,7 day after the surgery respectively.

  3. The occurrence of cardiovascular events [ Time Frame: 30-day after surgery ]
    Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up

  4. The incidence of any adverse events [ Time Frame: 30-day after surgery ]
    Including kidney or brain related adverse events 30-day after surgery



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103633


Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Sponsors and Collaborators
The First Affiliated Hospital of Anhui Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT03103633    
Other Study ID Numbers: FirstAnhuiM
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Anhui Medical University:
oxygen dynamics
Prognosis
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases