Skip to main content
OpenTrials
Completed

NCT Number: NCT03103633

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Disease Behavior Cardiovascular Diseases Heart Diseases High Risk Sex Sexual Behavior Unsafe Sex

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent;
  • Selective cardiac surgery and general anesthesia patients;
  • Age 18-90 yrs;
  • Anesthesia Society of American (ASA) Scale II-IV
  • European System for Cardiac Operative Risk Evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50%

Exclusion criteria

  • Preoperative cardiac ejection fraction<30 %;
  • History of anesthesia awareness;
  • History or anticipation of difficult intubation;
  • Unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia;
  • long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.

Treatment and study plan

mean artery pressure

Procedure

mean artery pressure declined with less than 20% of baseline

bispectral index

Procedure

BIS 45-60 before and after CPB; and BIS 40-45 during CPB

Other names: BIS

Brain oxygen saturation

Procedure

Brain oxygen saturation declined with less than 20% of baseline

Controlled

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.