NCT03103633

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: The First Affiliated Hospital of Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cardiac Disease
• High Risk Sex

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2017-03-05
• Primary completion: 2018-06-30
• Completion: 2018-07-30
• First posted: 2017-04-06
• Last updated: 2019-03-25

Locations

1 site across 1 country: China