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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03103633
Other study ID # FirstAnhuiM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2017
Est. completion date July 30, 2018

Study information

Verified date April 2017
Source The First Affiliated Hospital of Anhui Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date July 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
mean artery pressure
mean artery pressure declined with less than 20% of baseline
bispectral index
BIS 45-60 before and after CPB; and BIS 40-45 during CPB
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.

Locations

Country Name City State
China The First Affiliated Hospital of Anhui Medical University Hefei Anhui

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis) Number of Participants with major complications extracted after 30-day follow-up 30-day after surgery
Primary 30-day mortality Data for duration of postoperative 30-day all-cause mortality 30-day after surgery
Primary The change of incidence of postoperative delirium Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium The 1,2,3 day after surgery
Primary 1,3,5-year mortality Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up 1,3,5-year after surgery
Secondary postoperative hospital stay Data for duration of postoperative hospital stay is extracted after 30-day follow-up 30-day after surgery
Secondary The change of incidence of postoperative cognition dysfunction The neuropsychological tests performed at the day before the surgery,the 3,7 day after the surgery respectively. 1 day before surgery, the 3,7 day after the surgery
Secondary The occurrence of cardiovascular events Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up 30-day after surgery
Secondary The incidence of any adverse events Including kidney or brain related adverse events 30-day after surgery 30-day after surgery
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