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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

Tracking Information
First Submitted Date  ICMJE April 1, 2017
First Posted Date  ICMJE April 6, 2017
Last Update Posted Date March 25, 2019
Actual Study Start Date  ICMJE March 5, 2017
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • 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
  • 30-day mortality [ Time Frame: 30-day after surgery ]
    Data for duration of postoperative 30-day all-cause mortality
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • postoperative hospital stay [ Time Frame: 30-day after surgery ]
    Data for duration of postoperative hospital stay is extracted after 30-day follow-up
  • postoperative 30-day all-cause mortality [ Time Frame: 30-day after surgery ]
    Data for duration of postoperative 30-day all-cause mortality is extracted after 30-day follow-up
  • 1-year mortality [ Time Frame: 1-year after surgery ]
    Data for duration of 1-year all-cause mortality is extracted after 1-year follow-up
  • intermediate-term mortality [ Time Frame: 3-year after surgery ]
    Data for duration of 3-year all-cause mortality is extracted after 1-year follow-up
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • postoperative hospital stay [ Time Frame: 30-day after surgery ]
    Data for duration of postoperative hospital stay is extracted after 30-day follow-up
  • 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.
  • 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
  • The incidence of any adverse events [ Time Frame: 30-day after surgery ]
    Including kidney or brain related adverse events 30-day after surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • The change of incidence of postoperative delirium [ Time Frame: The 1,2,3 day after surgery ]
    Through CAM-ICU to assess the incidence of the postoperative delirium
  • 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.
  • 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
  • The incidence of any adverse events [ Time Frame: 30-day after surgery ]
    Including kidney or brain related adverse events 30-day after surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery
Official Title  ICMJE 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.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cardiac Disease
  • High Risk Sex
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: mean artery pressure
    • Procedure: bispectral index
    • Procedure: Brain oxygen saturation
  • 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.
    Intervention: Other: Controlled
Publications * Cheng XQ, Zhang JY, Wu H, Zuo YM, Tang LL, Zhao Q, Gu EW. Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial. J Clin Anesth. 2020 Sep 1;67:110032. doi: 10.1016/j.jclinane.2020.110032. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
286
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
240
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03103633
Other Study ID Numbers  ICMJE FirstAnhuiM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party The First Affiliated Hospital of Anhui Medical University
Study Sponsor  ICMJE The First Affiliated Hospital of Anhui Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of Anhui Medical University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP