Cardiac DiseaseNCT03103633

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

A study testing mean artery pressure, bispectral index and Brain oxygen saturation in people with Cardiac Disease and High Risk Sex, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Cardiac Disease, High Risk Sex
What is being tested?: mean artery pressure, bispectral index and Brain oxygen saturation
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 286 participants
Where: 1 siteChina
Study dates: 5 Mar 2017to 30 Jul 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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.

Conditions: Cardiac Disease, High Risk Sex
Being tested: mean artery pressure, bispectral index, Brain oxygen saturation, Controlled
Keywords: oxygen dynamics, Prognosis
Medical subject headings: Heart Diseases, Unsafe Sex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mean artery pressureProcedure or surgery
mean artery pressure declined with less than 20% of baseline
bispectral indexProcedure or surgery
Also called BIS
BIS 45-60 before and after CPB; and BIS 40-45 during CPB
Brain oxygen saturationProcedure or surgery
Brain oxygen saturation declined with less than 20% of baseline
ControlledOther
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 groups in NCT03103633
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Controlled

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 30-day after surgery
30-day mortality
Data for duration of postoperative 30-day all-cause mortality
Measured: 30-day after surgery
The change of incidence of postoperative delirium
Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium
Measured: 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
Measured: 1,3,5-year after surgery

Secondary outcomes (4)

postoperative hospital stay
Data for duration of postoperative hospital stay is extracted after 30-day follow-up
Measured: 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.
Measured: 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
Measured: 30-day after surgery
The incidence of any adverse events
Including kidney or brain related adverse events 30-day after surgery
Measured: 30-day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 201730 Jul 2018

First posted6 Apr 2017
Study start5 Mar 2017
Primary completion30 Jun 2018
Study completion30 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 286 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03103633
Sponsor's protocol ID: FirstAnhuiM
Status last verified: Apr 2017
First submitted: 1 Apr 2017
Last updated: 25 Mar 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 32889413

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

All Cardiac Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03103633
Acronym / sponsor ID: FirstAnhuiM
Conditions: Cardiac Disease, High Risk Sex
Keywords: oxygen dynamics, Prognosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 286 participants (actual)
Lead sponsor: The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
Study start: 5 Mar 2017 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 30 Jul 2018 (actual)
First posted: 6 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Individualized Goal-Directed Therapy	Experimental	Procedure: mean artery pressure, Procedure: bispectral index, Procedure: Brain oxygen saturationThe 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.
Controlled	Sham comparator	Other: Controlledno 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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%

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mean artery pressuremean artery pressure declined with less than 20% of baseline	Procedure or surgery	Individualized Goal-Directed Therapy
bispectral indexAlso: BISBIS 45-60 before and after CPB; and BIS 40-45 during CPB	Procedure or surgery	Individualized Goal-Directed Therapy
Brain oxygen saturationBrain oxygen saturation declined with less than 20% of baseline	Procedure or surgery	Individualized Goal-Directed Therapy
Controlledreceiving 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

Primary outcome

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
30-day mortality
Time frame: 30-day after surgery
Data for duration of postoperative 30-day all-cause mortality
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
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

4 secondary outcomes

postoperative hospital stay
Time frame: 30-day after surgery
The change of incidence of postoperative cognition dysfunction
Time frame: 1 day before surgery, the 3,7 day after the surgery
The occurrence of cardiovascular events
Time frame: 30-day after surgery
The incidence of any adverse events
Time frame: 30-day after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
Derived from this study: PubMed 32889413Cheng 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.
Individual participant dataSharing planned: Undecided

Related trials for Cardiac Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03103633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.