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

NCT03103633 | Completed DMC

• 1 other identifier: FirstAnhuiM
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oxygen dynamics; Prognosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• postoperative hospital stay

  30-day after surgery

• The change of incidence of postoperative cognition dysfunction

  1 day before surgery, the 3,7 day after the surgery

• The occurrence of cardiovascular events

  30-day after surgery

• The incidence of any adverse events

  30-day after surgery

Study Arms (2)

Individualized Goal-Directed Therapy

EXPERIMENTAL

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; Procedure: bispectral index; Procedure: Brain oxygen saturation

Controlled

SHAM COMPARATOR

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

Interventions

mean artery pressure PROCEDURE

mean artery pressure declined with less than 20% of baseline

Individualized Goal-Directed Therapy

bispectral index PROCEDURE

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

Also known as: BIS

Individualized Goal-Directed Therapy

Brain oxygen saturation PROCEDURE

Brain oxygen saturation declined with less than 20% of baseline

Individualized Goal-Directed Therapy

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.

Controlled

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Related Publications (1)

• 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.

  PMID: 32889413 DERIVED

MeSH Terms

Conditions

Heart Diseases; Unsafe Sex

Interventions

Consciousness Monitors; Control Groups

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were followed up by an investigator unaware of the patients' achievement or not of the oxygen dynamic goal
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional group:MAP 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. Control group：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.

Study Record Dates

• First Submitted: April 1, 2017
• First Posted: April 6, 2017
• Study Start: March 5, 2017
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: March 25, 2019

Record last verified: 2017-04

Locations

CN (1)