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

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.

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).

Study Overview

• Status: Completed
• Conditions: Cardiac Disease; High Risk Sex
• Intervention / Treatment: Procedure: mean artery pressure; Procedure: bispectral index; Procedure: Brain oxygen saturation; Other: Controlled

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
30-day mortality	Data for duration of postoperative 30-day all-cause mortality	30-day after surgery
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative hospital stay	Data for duration of postoperative hospital stay is extracted after 30-day follow-up	30-day after surgery
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
The occurrence of cardiovascular events	Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up	30-day after surgery
The incidence of any adverse events	Including kidney or brain related adverse events 30-day after surgery	30-day after surgery

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University

Publications and helpful links

General 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 Dec;67:110032. doi: 10.1016/j.jclinane.2020.110032. Epub 2020 Sep 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2017
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): July 30, 2018

Study Registration Dates

• First Submitted: April 1, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (ACTUAL): April 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Prognosis; oxygen dynamics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: FirstAnhuiM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No