Protective effect of ROCK inhibitor risudil on in vitro bacterial infection model of human peripheral blood derived macrophages
- Conditions
- Sepsis
- Registration Number
- ChiCTR2400088963
- Lead Sponsor
- Hangzhou First People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Criteria for inclusion of healthy volunteers<br>(1) Healthy subjects, male or female, 18-35 years old, never smoked, have a cigarette test, and are in good health;<br>(2) Body mass index 19-26, male weight =50 kg, female weight =45 kg;<br>(3) Fully understand and voluntarily sign informed consent.<br>2.Inclusion criteria for patients with sepsis<br>Referring to the International Guidelines for Sepsis, sepsis is diagnosed in patients with infection or suspected infection when the sepsis associated Sequential Organ Failure (SOFA) score (see Table 1) increases by =2 points from baseline.<br>3. Inclusion criteria of control group patients<br>Patients requiring continuous close monitoring and support of vital indicators after major surgical operations.
1.Exclusion criteria for healthy volunteers<br>Subjects will not be enrolled in this study if any of the following criteria are met:<br>(1) Participants in any drug clinical trial within 3 months before the trial;<br>(2) Chronic or active gastrointestinal diseases such as esophageal diseases, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding or gastrointestinal surgery within three years;<br>(3) Patients with a medical history of cardiovascular system, endocrine system, urinary system, nervous system, respiratory system, hematology, immunology (including personal or family history of inherited immune deficiency), psychiatry, metabolic abnormalities, etc., and researchers believe that the current clinical significance;<br>(4) Have a history of drug, food or other substance allergy;<br>(5) Patients with a history of tumor, epilepsy, recurrent headache, and tuberculosis infection;<br>(6) Patients who cannot tolerate venous puncture or have a history of fainting blood and fainting needles;<br>(7) Patients who had undergone surgery within 6 months before the trial that the researchers judged would affect drug absorption, distribution, metabolism, and excretion; Had a surgical procedure within 3 months prior to the trial; Or plan to have surgery during the study period;<br>(8) Those vaccinated within 3 months before the trial;<br>(9) Use of any drug within 30 days before the trial;<br>(10) Blood donors or large blood loss (> 400 mL) within 3 months before the test;<br>Alcoholics or regular drinkers in the six months preceding the trial, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or unwilling to stop drinking or using any alcoholic products during the trial; Or a positive breath test for alcohol (> 0.0 mg/100 mL);<br>(12) Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day, or did not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial period;<br>(13) eating any diet (including grapefruit or grapefruit products, oranges, tangerines, strawberries, apricots, xanthine, etc.) within 7 days prior to taking the study drug that may affect the metabolism of the drug in the body, or any other diet that the investigator considers to affect the absorption, distribution, metabolism, excretion of the drug, or does not agree to stop eating the above diet during the study;<br>(14) Those who have special requirements for diet, cannot comply with a uniform diet, or are lactose intolerant;<br>(15) The female subject had unprotected sex in the 2 weeks prior to the trial, or the subject had plans for pregnancy, sperm and egg donation in the 6 months from screening to the end of the trial, or was unwilling to use one or more non-drug contraceptive methods (such as total abstinence, contraceptive ring, partner ligation, etc.) during the trial;<br>(16) Drug abusers or those who have used soft drugs (e.g., cannabis) within 3 months prior to the trial or hard drugs (e.g., cocaine, PCP, etc.) within 1 year prior to the trial;<br>(17) Creatinine clearance < 80 mL/min {The Cockcroft-Gault formula for creatinine clearance calculation: CrCl=[(140- age)× body weight (kg)]/[0.814×Scr(µmol/L)], the unit of creatinine should be paid attention to during the calculation of creatinine clearance; For females, the calculated result was x 0.85. };<br>(18) Positive results of urine screening (morphine, methamphetamine, ketamine, dimethylene
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Macrophage pyrosis;
- Secondary Outcome Measures
Name Time Method NLRP3/Caspase-1/IL-1ß protein levels;IL-1ß protein levels;mRNA levels;