Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve Replacement Surgery (NCT04191642) | Clinical Trial Compass
CompletedNot Applicable
Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve Replacement Surgery
China75 participantsStarted 2019-04-01
Plain-language summary
The investigators decided to assess the prognostic value of NLRP3 inflammasome level in early after heart valve replacement surgery and whether it was related to postoperative cognitive dysfunction. Study population included 90 subjects. Neuropsychological tests were administrated one day before surgery and seven days after surgery. Before induction of anesthesia, before the end of the operation, 7 days after the operation, peripheral venous blood was sampled to measure IL-1B, IL-18 and NLRP3 inflammatory protein expression in peripheral blood monocytes. Analyze the data and draw conclusions.
Who can participate
Age range
60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients were included if they had an American Society of Anesthesiologists status of II or III and older than 60 years old.
Exclusion Criteria:
* A preoperative history of liver or kidney dysfunction, peripheral vascular disease, diabetes mellitus, or arterial hypertension;
* Ischemic cerebrovascular disease;
* A history of an acute or evolving myocardial infarction or presentation with a left ventricular ejection fraction (LVEF) of less than 45%;
* Obesity (body mass index 430 kg/m2);
* Moderate or severe atherosclerotic lesions in the ascending aorta or carotid artery stenosis confirmed by preoperative ultrasonography
* Patients requiring re-exploration after surgery or a total CPB time more than 115 min
* Patients requiring highdose pharmacologic support (phenylephrine 4 100 mg bolus, or epinephrine 4 0.1mg/kg/min or both) to maintain hemodynamic stability (mean arterial pressure \[MAP\] more than 60 mmHg)
Questions worth asking your doctor
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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?
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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?
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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
The correlation between peripheral blood NLRP3 inflammasome level and incidence of postoperative cognitive dysfunction
Timeframe: The day before surgery, 7 days after surgery
Trial details
NCT IDNCT04191642
SponsorGeneral Hospital of Ningxia Medical University