Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Manage… (NCT03527758) | Clinical Trial Compass
CompletedNot Applicable
Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management
Italy40 participantsStarted 2018-11-01
Plain-language summary
Intraoperative hypotension (defined as mean arterial pressure below 65 mmHg) is associated with increased organs dysfunction and mortality. Even short durations of reduced arterial blood pressure episodes significantly increased the risk of myocardial injury, neurological deficits, renal failure, and mortality. Hypotension rate during surgery is quite common and recent studies showed an incidence up to 60% of patients endured hypotension during anesthesia for an average of 10% of surgical time.
Nowadays hypotension seems to be preventable even if current management of the hypotensive episodes is predominantly reactive and rather occurs with some delay.
The investigators hypothesize that the prevention of hypotension by means Edwards Lifesciences new technology (HPI software) can improve patients outcome after surgery.
The present pilot randomized clinical trial is aimed at investigating various biomarkers involved in organ dysfunction and how they correlate with different intraoperative hypotension management strategies (Invasive blood pressure monitored by a normal arterial line vs Invasive blood pressure monitored by Edwards FloTracIQ system with HPI software).
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or older;
* Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours;
* Planned to receive general anesthesia;
* Planned to receive an arterial line during surgery;
* Aim for MAP of 65 mmHg during surgery;
* Being able to give written informed consent prior to surgery.
Exclusion Criteria:
Age less than 18 years;
* Aim for MAP other than 65 mmHg at discretion treating physician;
* Significant hypotension before surgery defined as a MAP \<65;
* Right- or left sided cardiac failure \[e.g. left ventricular ejection fraction (LVEF)\<35%\];
* Known cardiac shunts (significant);
* Known aortic stenosis (severe);
* Severe cardiac arrhythmias including atrial fibrillation;
* Chronic kidney disease (as chronic kidney disease may affect the interpretation and prognostic significance of changes in urinary biomarkers);
* Liver surgery;
* Vascular surgery with clamping of the aorta;
* Diabetes.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury.
Timeframe: 2 hours after starting anesthesia
2
Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury.