InflammasomesNCT04191642
Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve Replacement Surgery
An observational study of Inflammasomes and Cognitive Dysfunction, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Inflammasomes, Cognitive Dysfunction, Pyrin Domain-Containing 3 Protein
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Jan 2021
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly heart surgery patients
Who may be able to join
- Patients were included if they had an American Society of Anesthesiologists status of II or III and older than 60 years old.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve
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.
Read the detailed description
90 consecutive patients scheduled for mitral valve replacement or aortic valve replacement under moderate hypothermic CPB gave written informed consent and were enrolled in this study.
In the operating room, patients received routine monitoring. Systemic arterial blood pressure was measured via radial artery catheterization. After induction of anesthesia, a central venous catheter was inserted for monitoring central venous pressure (CVP) and fluid management. Baseline readings of hemodynamics were taken every 5 to 10 min after radial artery cannulation was completed.
Induction of anesthesia was performed with target-controlled infusion of propofol. All patients received an infused scheme of several steps that started from a target plasma concentration (Cp) of 0.5 mg/mL that was increased stepwise by 0.5 mg/mL until the patient fell asleep and maintain BIS at 40-60. The interval between each step was 3 min. After loss of consciousness, cisatracurium (0.2 mg/kg) and fentanyl (10-15 mg/kg) were infused in all groups. The trachea was intubated and the lungs were ventilated with oxygenenriched air (fraction of inspired oxygen 0.6) to an end-tidal carbon dioxide partial pressure of 35 to 45 mmHg. The propofol target Cp was adjusted according to BIS. Intermittent IV boluses of fentanyl (10-15 mg/kg) were administered according to blood pressure and heart rate (HR) at the following time points: before the skin incision, before the onset of CPB, and after separation from CPB, for a total dose of 40 to 50 mg/kg. All patients received infusion of cisatracurium at 0.1 mg/kg/h throughout the surgery.
Surgery was conducted on all patients via a standard median sternotomy approach. Porcine heparin was administered at a dose of 300 IU/kg and supplemented when required to maintain an activated coagulation time of at least 480 s during CPB. Heparin was neutralized with 1 mg of protamine/100 IU of heparin administered after separation from CPB. Body temperature was cooled to 30℃-32℃ on CPB (moderate hypothermia). All patients were treated with an intermittent antegrade infusion of cooled high-potassium blood cardioplegia during continuous aortic cross-clamping (ACC) using a nonpulsatile flow rate of 1.8 to 2.8 L/min/m2 and a membrane oxygenator to keep the mixed venous saturation at more than 75% during CPB. Phenylephrine (bolus, 20-100 mg) or epinephrine (0.1 mg/kg/min) or both were used to restore systemic vascular resistance, and MAP was maintained at a target range of 60 to 80 mmHg. Patients were warmed to a bladder temperature of 36.5℃ before separation from CPB, with the highest temperature not exceeding 37℃. Blood remaining in the CPB circuit and from the surgical field was collected in a cell-saving device. After centrifuging and washing, it was infused to the patient within 4 hours after CPB. Hematocrit was maintained at more than 25%, with the addition of blood as necessary. Insulin therapy was initiated during the surgery to treat serum blood glucose levels higher than 150 mg/dL. Hemodynamic (pre- or post-CPB) management aimed to keep MAP at 60 to 100 mmHg. Hypertension was treated with an additional bolus dose of fentanyl (0.2-0.3 mg) or with nitroglycerin (0.1-0.5 mg/kg/min or with both). Hypotension was treated with fluid intake (including crystalloids, colloids, and blood products) or vasoactive drug administration (phenylephrine IV, 20-100 mg or concomitant use of epinephrine, o 0.1 mg/min). The vasoactive drug dosage, fluid intake, and output (urine and blood loss) were recorded when the surgery was finished.
As the surgeons began to close the skin, a 0.08 mg/kg bolus dose of midazolam was given intravenously and the infusion of propofol was stopped. After the surgery, all patients were admitted to the surgical intensive care unit (ICU). The patients were extubated when they were able to sustain adequate spontaneous respiration and required minimal oxygen support, as reflected by normal arterial blood gas levels. The patients then were discharged from the ICU when they were hemodynamically stable with blood gas variables within the normal range and when they did not need inotropic or oxygen support. The tracheal extubation time and the length of the ICU stay were recorded. For all patients, hemodynamic measurements were made and recorded at the following times: Before induction of anesthesia, before skin incision, after sternotomy, at the cessation of CPB (CPB-cessation), and at 1 (Post-CPB 1 h), 2 (Post-CPB 2 h), and 4 (Post-CPB 4 h) hours after CPB. At pre-incision, CPB-cessation, Post-CPB 2 h, and PostCPB 4 h, the radial arterial blood was sampled for blood gas analysis, as well as blood glucose and lactic acid analyses. Before induction of anesthesia, at 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.
Neuropsychological tests were administrated one day before surgery and seven days after surgery for all patients in a quiet place of the general wards. Neuropsychological tests included seven tests with nine subscales. Specific tests used were as follows: MMSE, Trail Making (A/B), Stroop Color- Word, Rey Auditory Verbal Learning Test, WAIS Digit Symbol Substitution Test, WAIS Digit Span, Verbal fluency test. Two psychologists carried out these tests. During the study phase, testing was performed and scored in a standardized manner in order to minimize inter-examiner difference. Repeat assessments for each patient were conducted by the same examiner. Parallel forms of tests were used in a randomized manner in sequential testing in order to minimize practice effect. Performance on each test was compared with cognitive test data of control subjects. A low test score was defined when the score was ≥ 2 SD lower than control subjects. For tests in which a higher score indicates decrement in performance, a score ≥ 2 SD higher than control subjects was considered as "low test score." Patients were defined as having preoperative cognitive impairment if they had low test scores on two or more tests.
For patients, preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The test results were adjusted so that a positive Z score indicated deterioration from the baseline test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score. A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more.
Statistical analysis A continuous outcome was expressed as the mean ± SE, while a categorical outcome was expressed as percentages or frequencies. Differences in continuous and categorical outcomes were tested using the one-way analysis of variance and Chi square analysis, respectively. The unpaired Student t test, paired T test, analysis of variance and Pearson correlation analysis were performed on normally distributed data. Case-control differences in nominal data were evaluated with the Chi square test. Multivariate Cox regression analysis was done for predictors of adverse events. The NLRP3 level, IL-1B, IL-18 and neurobehavioral scores were compared using ROC curves. Kaplan-Meier curves were used for correlation with POCD. All statistical analyses were performed with SPSS 21.0 (IBM Inc.) and P < 0.05 was considered signifcant.
- Conditions
- Inflammasomes, Cognitive Dysfunction, Pyrin Domain-Containing 3 Protein, Postoperative Complications
- Keywords
- Inflammasomes, Interleukin-18, Interleukin-1, NLR Family, Pyrin Domain-Containing 3 Protein, Postoperative cognitive dysfunction
- Medical subject headings
- Cognitive Dysfunction, Postoperative Complications, Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between peripheral blood NLRP3 inflammasome level and incidence of postoperative cognitive dysfunction
Peripheral venous blood was sampled to measure NLRP3 inflammasome expression.
POCD was defined by Z scores that based on the neuropsychological tests, and then, get the incidence of POCD.
The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more.
Neuropsychological tests included MMSE(screening method); Trail Making (A/B); Stroop Color-Word; Rey Auditory Verbal Learning Test; WAIS Digit Symbol Substitution Test; WAIS Digit Span; Verbal fluency test.
Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score.
Measured: The day before surgery, 7 days after surgery
Secondary outcomes (2)
The correlation between peripheral blood IL-1B levels and incidence of postoperative cognitive dysfunction
Peripheral venous blood was sampled to measure IL-1B expression.
POCD was defined by Z scores that based on the neuropsychological tests, and then, get the incidence of POCD.
The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more.
Neuropsychological tests included MMSE(screening method); Trail Making (A/B); Stroop Color-Word; Rey Auditory Verbal Learning Test; WAIS Digit Symbol Substitution Test; WAIS Digit Span; Verbal fluency test.
Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score.
Measured: At the end of the surgery, 7 days after surgery
The correlation between peripheral blood IL-18 levels and incidence of postoperative
Peripheral venous blood was sampled to measure IL-18 expression.
POCD was defined by Z scores that based on the neuropsychological tests, and then, get the incidence of POCD.
The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more.
Neuropsychological tests included MMSE(screening method); Trail Making (A/B); Stroop Color-Word; Rey Auditory Verbal Learning Test; WAIS Digit Symbol Substitution Test; WAIS Digit Span; Verbal fluency test.
Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score.
Measured: At the end of the surgery, 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Apr 2019
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InflammasomesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Ma, doctor, Study director, Department of Anesthesiology General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191642
- Sponsor's protocol ID
- Magang2018-020
- Status last verified
- Aug 2021
- First submitted
- 27 Nov 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Afrasyab A, Qu P, Zhao Y, Peng K, Wang H, Lou D, Niu N, Yuan D. Correlation of NLRP3 with severity and prognosis of coronary atherosclerosis in acute coronary syndrome patients. Heart Vessels. 2016 Aug;31(8):1218-29. doi: 10.1007/s00380-015-0723-8. Epub 2015 Aug 20.
PubMed 26290166Meital LT, Coward AS, Windsor MT, Bailey TG, Kuballa A, Russell FD. A simple and effective method for the isolation and culture of human monocytes from small volumes of peripheral blood. J Immunol Methods. 2019 Sep;472:75-78. doi: 10.1016/j.jim.2019.04.005. Epub 2019 Jun 20.
PubMed 31229469Lenart N, Brough D, Denes A. Inflammasomes link vascular disease with neuroinflammation and brain disorders. J Cereb Blood Flow Metab. 2016 Oct;36(10):1668-1685. doi: 10.1177/0271678X16662043. Epub 2016 Aug 2.
PubMed 27486046Feinkohl I, Winterer G, Spies CD, Pischon T. Cognitive Reserve and the Risk of Postoperative Cognitive Dysfunction. Dtsch Arztebl Int. 2017 Feb 17;114(7):110-117. doi: 10.3238/arztebl.2017.0110.
PubMed 28302254Cao XZ, Ma H, Wang JK, Liu F, Wu BY, Tian AY, Wang LL, Tan WF. Postoperative cognitive deficits and neuroinflammation in the hippocampus triggered by surgical trauma are exacerbated in aged rats. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Dec 1;34(8):1426-32. doi: 10.1016/j.pnpbp.2010.07.027. Epub 2010 Aug 4.
PubMed 20691747Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.
PubMed 20818791Song L, Pei L, Yao S, Wu Y, Shang Y. NLRP3 Inflammasome in Neurological Diseases, from Functions to Therapies. Front Cell Neurosci. 2017 Mar 9;11:63. doi: 10.3389/fncel.2017.00063. eCollection 2017.
PubMed 28337127Murkin JM, Newman SP, Stump DA, Blumenthal JA. Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery. Ann Thorac Surg. 1995 May;59(5):1289-95. doi: 10.1016/0003-4975(95)00106-u. No abstract available.
PubMed 7733754Rudolph JL, Schreiber KA, Culley DJ, McGlinchey RE, Crosby G, Levitsky S, Marcantonio ER. Measurement of post-operative cognitive dysfunction after cardiac surgery: a systematic review. Acta Anaesthesiol Scand. 2010 Jul;54(6):663-77. doi: 10.1111/j.1399-6576.2010.02236.x. Epub 2010 Apr 15.
PubMed 20397979Ma G, Sun P, Chen Y, Jiang X, Zhang C, Qu B, Meng X. NLRP3 inflammasome activation contributes to the cognitive decline after cardiac surgery. Front Surg. 2022 Nov 2;9:992769. doi: 10.3389/fsurg.2022.992769. eCollection 2022.
PubMed 36406365
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve
- ClinicalTrials.gov ID
- NCT04191642
- Acronym / sponsor ID
- Magang2018-020
- Conditions
- Inflammasomes, Cognitive Dysfunction, Pyrin Domain-Containing 3 Protein, Postoperative Complications
- Keywords
- Inflammasomes, Interleukin-18, Interleukin-1, NLR Family, Pyrin Domain-Containing 3 Protein, Postoperative cognitive dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 10 Dec 2019 (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.
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.
Detailed description
90 consecutive patients scheduled for mitral valve replacement or aortic valve replacement under moderate hypothermic CPB gave written informed consent and were enrolled in this study.
In the operating room, patients received routine monitoring. Systemic arterial blood pressure was measured via radial artery catheterization. After induction of anesthesia, a central venous catheter was inserted for monitoring central venous pressure (CVP) and fluid management. Baseline readings of hemodynamics were taken every 5 to 10 min after radial artery cannulation was completed.
Induction of anesthesia was performed with target-controlled infusion of propofol. All patients received an infused scheme of several steps that started from a target plasma concentration (Cp) of 0.5 mg/mL that was increased stepwise by 0.5 mg/mL until the patient fell asleep and maintain BIS at 40-60. The interval between each step was 3 min. After loss of consciousness, cisatracurium (0.2 mg/kg) and fentanyl (10-15 mg/kg) were infused in all groups. The trachea was intubated and the lungs were ventilated with oxygenenriched air (fraction of inspired oxygen 0.6) to an end-tidal carbon dioxide partial pressure of 35 to 45 mmHg. The propofol target Cp was adjusted according to BIS. Intermittent IV boluses of fentanyl (10-15 mg/kg) were administered according to blood pressure and heart rate (HR) at the following time points: before the skin incision, before the onset of CPB, and after separation from CPB, for a total dose of 40 to 50 mg/kg. All patients received infusion of cisatracurium at 0.1 mg/kg/h throughout the surgery.
Surgery was conducted on all patients via a standard median sternotomy approach. Porcine heparin was administered at a dose of 300 IU/kg and supplemented when required to maintain an activated coagulation time of at least 480 s during CPB. Heparin was neutralized with 1 mg of protamine/100 IU of heparin administered after separation from CPB. Body temperature was cooled to 30℃-32℃ on CPB (moderate hypothermia). All patients were treated with an intermittent antegrade infusion of cooled high-potassium blood cardioplegia during continuous aortic cross-clamping (ACC) using a nonpulsatile flow rate of 1.8 to 2.8 L/min/m2 and a membrane oxygenator to keep the mixed venous saturation at more than 75% during CPB. Phenylephrine (bolus, 20-100 mg) or epinephrine (0.1 mg/kg/min) or both were used to restore systemic vascular resistance, and MAP was maintained at a target range of 60 to 80 mmHg. Patients were warmed to a bladder temperature of 36.5℃ before separation from CPB, with the highest temperature not exceeding 37℃. Blood remaining in the CPB circuit and from the surgical field was collected in a cell-saving device. After centrifuging and washing, it was infused to the patient within 4 hours after CPB. Hematocrit was maintained at more than 25%, with the addition of blood as necessary. Insulin therapy was initiated during the surgery to treat serum blood glucose levels higher than 150 mg/dL. Hemodynamic (pre- or post-CPB) management aimed to keep MAP at 60 to 100 mmHg. Hypertension was treated with an additional bolus dose of fentanyl (0.2-0.3 mg) or with nitroglycerin (0.1-0.5 mg/kg/min or with both). Hypotension was treated with fluid intake (including crystalloids, colloids, and blood products) or vasoactive drug administration (phenylephrine IV, 20-100 mg or concomitant use of epinephrine, o 0.1 mg/min). The vasoactive drug dosage, fluid intake, and output (urine and blood loss) were recorded when the surgery was finished.
As the surgeons began to close the skin, a 0.08 mg/kg bolus dose of midazolam was given intravenously and the infusion of propofol was stopped. After the surgery, all patients were admitted to the surgical intensive care unit (ICU). The patients were extubated when they were able to sustain adequate spontaneous respiration and required minimal oxygen support, as reflected by normal arterial blood gas levels. The patients then were discharged from the ICU when they were hemodynamically stable with blood gas variables within the normal range and when they did not need inotropic or oxygen support. The tracheal extubation time and the length of the ICU stay were recorded. For all patients, hemodynamic measurements were made and recorded at the following times: Before induction of anesthesia, before skin incision, after sternotomy, at the cessation of CPB (CPB-cessation), and at 1 (Post-CPB 1 h), 2 (Post-CPB 2 h), and 4 (Post-CPB 4 h) hours after CPB. At pre-incision, CPB-cessation, Post-CPB 2 h, and PostCPB 4 h, the radial arterial blood was sampled for blood gas analysis, as well as blood glucose and lactic acid analyses. Before induction of anesthesia, at 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.
Neuropsychological tests were administrated one day before surgery and seven days after surgery for all patients in a quiet place of the general wards. Neuropsychological tests included seven tests with nine subscales. Specific tests used were as follows: MMSE, Trail Making (A/B), Stroop Color- Word, Rey Auditory Verbal Learning Test, WAIS Digit Symbol Substitution Test, WAIS Digit Span, Verbal fluency test. Two psychologists carried out these tests. During the study phase, testing was performed and scored in a standardized manner in order to minimize inter-examiner difference. Repeat assessments for each patient were conducted by the same examiner. Parallel forms of tests were used in a randomized manner in sequential testing in order to minimize practice effect. Performance on each test was compared with cognitive test data of control subjects. A low test score was defined when the score was ≥ 2 SD lower than control subjects. For tests in which a higher score indicates decrement in performance, a score ≥ 2 SD higher than control subjects was considered as "low test score." Patients were defined as having preoperative cognitive impairment if they had low test scores on two or more tests.
For patients, preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The test results were adjusted so that a positive Z score indicated deterioration from the baseline test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score. A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more.
Statistical analysis A continuous outcome was expressed as the mean ± SE, while a categorical outcome was expressed as percentages or frequencies. Differences in continuous and categorical outcomes were tested using the one-way analysis of variance and Chi square analysis, respectively. The unpaired Student t test, paired T test, analysis of variance and Pearson correlation analysis were performed on normally distributed data. Case-control differences in nominal data were evaluated with the Chi square test. Multivariate Cox regression analysis was done for predictors of adverse events. The NLRP3 level, IL-1B, IL-18 and neurobehavioral scores were compared using ROC curves. Kaplan-Meier curves were used for correlation with POCD. All statistical analyses were performed with SPSS 21.0 (IBM Inc.) and P < 0.05 was considered signifcant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly heart surgery patients
Key inclusion criteria (1 listed)
- Patients were included if they had an American Society of Anesthesiologists status of II or III and older than 60 years old.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between peripheral blood NLRP3 inflammasome level and incidence of postoperative cognitive dysfunction
Time frame: The day before surgery, 7 days after surgery
Peripheral venous blood was sampled to measure NLRP3 inflammasome expression. POCD was defined by Z scores that based on the neuropsychological tests, and then, get the incidence of POCD. The method of Z scores is as follows: A patient was defined as having POCD when two Z scores in individual tests or the combined Z score were 1.96 or more. Neuropsychological tests included MMSE(screening method); Trail Making (A/B); Stroop Color-Word; Rey Auditory Verbal Learning Test; WAIS Digit Symbol Substitution Test; WAIS Digit Span; Verbal fluency test. Preoperative scores were compared with postoperative test results, subtracted the average practice effect from these changes, and then divided the result by the control-subject SD to obtain a Z score for each test. The Z scores of all tests in an individual patient were then summarized and divided by the SD for this sum of Z scores in the control subjects, creating a combined Z score.
2 secondary outcomes
The correlation between peripheral blood IL-1B levels and incidence of postoperative cognitive dysfunction
Time frame: At the end of the surgery, 7 days after surgery
The correlation between peripheral blood IL-18 levels and incidence of postoperative
Time frame: At the end of the surgery, 7 days 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 1 Sep 2021.
- Results publication: PubMed 26290166Afrasyab A, Qu P, Zhao Y, Peng K, Wang H, Lou D, Niu N, Yuan D. Correlation of NLRP3 with severity and prognosis of coronary atherosclerosis in acute coronary syndrome patients. Heart Vessels. 2016 Aug;31(8):1218-29. doi: 10.1007/s00380-015-0723-8. Epub 2015 Aug 20.
- Results publication: PubMed 31229469Meital LT, Coward AS, Windsor MT, Bailey TG, Kuballa A, Russell FD. A simple and effective method for the isolation and culture of human monocytes from small volumes of peripheral blood. J Immunol Methods. 2019 Sep;472:75-78. doi: 10.1016/j.jim.2019.04.005. Epub 2019 Jun 20.
- Results publication: PubMed 27486046Lenart N, Brough D, Denes A. Inflammasomes link vascular disease with neuroinflammation and brain disorders. J Cereb Blood Flow Metab. 2016 Oct;36(10):1668-1685. doi: 10.1177/0271678X16662043. Epub 2016 Aug 2.
- Results publication: PubMed 28302254Feinkohl I, Winterer G, Spies CD, Pischon T. Cognitive Reserve and the Risk of Postoperative Cognitive Dysfunction. Dtsch Arztebl Int. 2017 Feb 17;114(7):110-117. doi: 10.3238/arztebl.2017.0110.
- Results publication: PubMed 20691747Cao XZ, Ma H, Wang JK, Liu F, Wu BY, Tian AY, Wang LL, Tan WF. Postoperative cognitive deficits and neuroinflammation in the hippocampus triggered by surgical trauma are exacerbated in aged rats. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Dec 1;34(8):1426-32. doi: 10.1016/j.pnpbp.2010.07.027. Epub 2010 Aug 4.
- Results publication: PubMed 20818791Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.
- Results publication: PubMed 28337127Song L, Pei L, Yao S, Wu Y, Shang Y. NLRP3 Inflammasome in Neurological Diseases, from Functions to Therapies. Front Cell Neurosci. 2017 Mar 9;11:63. doi: 10.3389/fncel.2017.00063. eCollection 2017.
- Results publication: PubMed 7733754Murkin JM, Newman SP, Stump DA, Blumenthal JA. Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery. Ann Thorac Surg. 1995 May;59(5):1289-95. doi: 10.1016/0003-4975(95)00106-u. No abstract available.
- Results publication: PubMed 20397979Rudolph JL, Schreiber KA, Culley DJ, McGlinchey RE, Crosby G, Levitsky S, Marcantonio ER. Measurement of post-operative cognitive dysfunction after cardiac surgery: a systematic review. Acta Anaesthesiol Scand. 2010 Jul;54(6):663-77. doi: 10.1111/j.1399-6576.2010.02236.x. Epub 2010 Apr 15.
- Derived from this study: PubMed 36406365Ma G, Sun P, Chen Y, Jiang X, Zhang C, Qu B, Meng X. NLRP3 inflammasome activation contributes to the cognitive decline after cardiac surgery. Front Surg. 2022 Nov 2;9:992769. doi: 10.3389/fsurg.2022.992769. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Inflammasomes
RecruitingObservational study
Association of Periodontal Status and Smoking With Salivary Inflammasome Markers
Periodontitis, Periodontal Disease
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.
Gang Ma, doctor study director
Department of Anesthesiology General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammasomes and Cognitive Dysfunction, run by General Hospital of Ningxia Medical University at 1 site in China.
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 1 inclusion and 7 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 1 Sep 2021. 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. 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?
The correlation between peripheral blood NLRP3 inflammasome level and incidence of postoperative cognitive dysfunction (time frame: The day before surgery, 7 days after surgery). 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 NCT04191642, which also lists 10 linked publications.
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 1 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.