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

Cardiac Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103633
• Other study ID #: FirstAnhuiM
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• High Risk Sex

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