[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604016":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":52,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":26,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"butyrate\u002Ftaurine group","EXPERIMENTAL","Interventional group (combination of taurine and butyrate): 4g of taurine plus 4.8g of sodium butyrate will be administered orally after enrolment on the day before surgery, and then daily thereafter for three months after surgery.",[13],"Dietary Supplement: Butyrate and Taurine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo control","PLACEBO_COMPARATOR","Placebo group: indistinguishable placebo capsules will be administered orally after enrolment on the day before surgery, followed by daily administration for three months after surgery. Both taurine, butyrate and the indistinguishable placebo capsules are white in color.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Butyrate and Taurine","This dose of butyrate is chosen to maximize any treatment effect in postoperative pain. Butyrate was reported to be safe at this dose for a prolonged period of 8 weeks. The dose of taurine is considered safe according to the European Food Safety Authority and was used in previous human perioperative trials. A human pharmacokinetic study showed that after taking 4g taurine (32 mmol) orally, plasma taurine levels reached a peak level of 86 mg\u002FL (or 0.7 mmol\u002FL) at 1.5 hours, exceeding the physiological plasma taurine level (0.01-0.1 mmol\u002FL), which is needed to exert its pharmacological benefits.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","indistinguishable placebo capsules will be administered orally after enrolment on the day before surgery, followed by daily administration for three months after surgery.",[15],[32],{"name":33,"affiliation":34,"role":35},"Henry Wong, MBChB","Department of Anaesthesia and Intensive Care, The Chinese University of Hong Hong","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","35052734","henrymkwong@cuhk.edu.hk",[42],{"facility":43,"status":26,"city":44,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":26},"Prince of Wales Hospital","Hong Kong","HK",{"type":47,"coordinates":48},"Point",[49,50],114.17469,22.27832,{"lat":50,"lon":49},{"type":35,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"WONG MAN KIN","Assistant Professor","100604016","butyrate-and-taurine-for-chronic-postsurgical-pain-in-adult-cardiac-surgical-patients-100604016",false,"NCT07144033","Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients","Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients: Bayesian Optimized Double-blinded Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients aged 18 or older\n* elective surgery\n* coronary artery bypass graft (CABG), valve repair\u002Freplacement, combined CABG\u002Fvalve procedure, or major aortic procedure via sternotomy\n\nExclusion Criteria:\n\n* emergency surgery\n* redo surgery\n* history of chronic pain or on chronic opioids\u002Fsedatives\n* already taking taurine or butyrate prior to enrolment\n* renal failure with estimated glomerular filtration rate \\\u003C30mL\u002Fmin (calculated by Cockcroft-Gault formula)\n* re-operation within 24 hours after surgery\n* intraoperative use of remifentanil\n* inability to provide informed consent.","ALL","18 Years",{"count":65,"type":66},216,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study is a single-center, phase II, randomized, placebo-controlled, Bayesian-designed, double-blinded trial\n\nGoal and Questions:\n\nThe primary goal is to evaluate if a combination of taurine and butyrate can reduce chronic postsurgical pain (CPSP) in adult cardiac surgical patients. The study also aims to determine if these compounds are safe, effective in perioperative pain control, and feasible for improving postoperative outcomes.\n\nParticipants:\n\nThe study will include adult patients (aged 18 or older) undergoing elective coronary artery bypass graft (CABG), valve repair\u002Freplacement, combined CABG\u002Fvalve, or major aortic procedure via sternotomy. Exclusion criteria include emergency surgery, redo surgery, a history of chronic pain or chronic opioid\u002Fsedative use, and an estimated glomerular filtration rate (eGFR) less than 30 mL\u002Fmin. The target sample size is 216 patients.\n\nIntervention group: Patients will receive 4g of taurine and 4.8g of sodium butyrate orally once daily, starting the day before surgery and continuing for three months post-surgery.\n\nPlacebo group: Patients will receive indistinguishable placebo capsules orally once daily, following the same schedule as the intervention group.\n\nPrimary Outcome: The incidence of chronic postsurgical pain at 3 months,\n\nSecondary Outcomes:\n\nQuality of Recovery Questionnaire (QoR-15) at 72 hours after extubation.\n\nPain scores (NRS) at rest and with movement at 12, 24, 48, and 72 hours post-extubation.\n\nPostoperative morphine requirements and time to first morphine rescue.\n\nIncidence of opioid-related side effects, such as postoperative nausea and vomiting (PONV).\n\nDuration of mechanical ventilation, and length of stay in the ICU and hospital.\n\nLong-term pain assessment using the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Brief Pain Inventory (BPI) Interference Scale, and Neuropathic Pain Questionnaire (NPQ) at 1, 3, 6, and 12 months post-surgery\n\nProteomic analysis:\n\nBlood samples within 72 hours after surgery will be collected for proteomic analysis to investigate predictors for chronic postsurgical pain.",[72,73,74],"Pain, Acute","Pain, Chronic","Chronic Post Operative Pain","NOT_YET_RECRUITING","2025-08-28",{"date":78,"type":79},"2025-09-05","ACTUAL",{"date":81,"type":66},"2026-01-01",{"date":83,"type":66},"2028-01-31",{"name":5,"class":6},1]