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Smart Monitoring Software for Noncardiac Surgery Outcomes
N/A
Recruiting
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start to end of non-cardiac surgery
Awards & highlights
Study Summary
This trial tests a new medical treatment compared to existing treatments to see how well it works.
Who is the study for?
The SMART TRENDS Study is for adults over 18 who are undergoing elective noncardiac surgery expected to last at least 3 hours with a post-op hospital stay of at least 3 days. Participants must be monitored with an arterial catheter under general anesthesia. Those with planned vasopressor use, contraindications to arterial monitoring, severe kidney issues, or on mechanical support can't join.Check my eligibility
What is being tested?
This study tests the Acumen HPI Smart Alerts and Smart Trends Software in patients having noncardiac surgery. It's a multicenter trial comparing outcomes using this software against past data from surgeries without it.See study design
What are the potential side effects?
Since this trial involves software rather than medication, traditional side effects aren't applicable. However, there may be risks associated with potential incorrect alerts or reliance on the technology that could affect patient management.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start to end of non-cardiac surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start to end of non-cardiac surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HPI Smart Alert
Trial Design
1Treatment groups
Experimental Treatment
Group I: SMART TRENDS ArmExperimental Treatment1 Intervention
Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,452 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced, with creatinine over 2.0 mg/dL or CKD stage above 3A.I need surgery urgently.I am scheduled for brain or heart surgery.I will receive medication to support my blood pressure during surgery.I cannot follow the study's surgery blood pressure or fluid management plan.I will be under general anesthesia with a breathing tube for my surgery.I am scheduled for a non-heart surgery that will last 3 hours or more and will stay in the hospital for at least 3 days after.I am 18 years old or older.I have a mild to severe systemic disease.
Research Study Groups:
This trial has the following groups:- Group 1: SMART TRENDS Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any individuals being accepted for participation in this trial at present?
"Affirmative. Per the information posted on clinicaltrials.gov, this clinical trial commenced recruiting on July 11th 2023 and was last updated recently on July 14th 2023. The study is searching for 122 individuals at one medical facility."
Answered by AI
How many participants are accepted for this trial's enrollment?
"Affirmative, the information published on clinicaltrials.gov reveals that this experiment is in need of participants. This trial was first advertised on July 11th 2023 and most recently updated a few days ago on July 14th 2023. Currently, 122 volunteers are needed from one medical centre."
Answered by AI
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