[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622034":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":54,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Aerospace Center Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GDTM Group","EXPERIMENTAL","Participants assigned to this group receive a protocolized, phase-based temperature management algorithm. This includes strict normothermia maintenance during cytoreduction, anticipatory pre-cooling prior to HIPEC perfusion, and proactive cooling during the hyperthermic phase to attenuate thermal variability .",[13],"Procedure: Proactive Goal-Directed Temperature Management",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care Group","ACTIVE_COMPARATOR","Participants receive standard institutional thermal management characterized by a reactive approach. Therapeutic interventions (warming or cooling) are determined by the attending anesthesiologist based on observed threshold violations (e.g., core temperature \\\u003C36.0°C or \\>38.5°C) rather than a prespecified goal-directed algorithm .",[19],"Procedure: Standard Reactive Temperature Management",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Proactive Goal-Directed Temperature Management","The protocol consists of four phases:\n\nCytoreductive Phase: Maintain core temperature 36.5-37.5°C.\n\nPre-cooling Phase: Initiated \\~30 min before HIPEC (e.g., during closure), targeting 36.0-36.3°C.\n\nHIPEC Phase: Proactive cooling to target 37.5-38.0°C; escalation triggered at 37.8°C. 4. Rewarming Phase: Restore 36.5-37.5°C prior to ICU transfer .",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Reactive Temperature Management","Hypothermia Management: Active warming initiated reactively only when core temperature falls below 36.0°C.\n\nPre-cooling: No anticipatory pre-cooling is performed. 3. HIPEC Phase: Active cooling withheld unless core temperature exceeds standard safety thresholds (typically \\>38.5°C) or for immediate safety indications .",[15],[32],{"name":33,"affiliation":5,"role":34},"Xiangli Zheng","STUDY_CHAIR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Xinrui Yin","CONTACT","+86-13029315156","ahywvn@pku.org.cn",[42],{"facility":5,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beijing","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":55,"investigatorFullName":37,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100622034","proactive-temperature-management-in-crs-hipec-for-prevention-of-delirium-100622034",false,"NCT07378371","Proactive Temperature Management in CRS-HIPEC for Prevention of Delirium","Proactive Temperature Management and Delirium After Cytoreductive Surgery With HIPEC: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients (aged 18-80 years).\n\nAmerican Society of Anesthesiologists (ASA) physical status of I to III.\n\nScheduled for elective Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Pseudomyxoma Peritonei (PMP).\n\nWritten informed consent obtained from the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Known diagnosis of dementia, major neurocognitive disorder, or severe psychiatric illness (e.g., schizophrenia) documented in the medical record.\n\nAcute central nervous system pathology likely to confound delirium assessment (e.g., recent stroke, active seizure disorder, or traumatic brain injury).\n\nSevere sensory or language barriers precluding valid cognitive screening (e.g., profound deafness or blindness, or language barriers not correctable with translation).\n\nPreoperative coma, mechanical ventilation, or deep sedation precluding reliable baseline assessment.\n\nEmergency surgery or repeat CRS-HIPEC during the same hospital admission.\n\nHistory of alcohol or substance abuse likely to precipitate withdrawal symptoms.","ALL","18 Years","80 Years",{"count":68,"type":69},174,"ESTIMATED","INTERVENTIONAL",[72],"NA","This randomized controlled trial evaluates the efficacy of a proactive Goal-Directed Temperature Management (GDTM) protocol in reducing postoperative delirium among patients undergoing Cytoreductive Surgery (CRS) with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for pseudomyxoma peritonei.\n\nCRS-HIPEC presents a unique physiological challenge characterized by a biphasic thermal trajectory: potential hypothermia during extensive surgery followed by rapid iatrogenic hyperthermia during perfusion. This study compares a standardized GDTM strategy-which incorporates strict normothermia maintenance and anticipatory pre-cooling prior to perfusion-against standard reactive thermal management. The primary objective is to determine if optimized thermoregulation can attenuate thermal variability and improve early neurocognitive recovery.",[75,76],"Pseudomyxoma Peritonei","Postoperative Delirium (POD)",[78,79,80,81,82],"Cytoreductive Surgery","HIPEC","Hyperthermic Intraperitoneal Chemotherapy","Temperature Management","Goal-Directed Therapy","NOT_YET_RECRUITING","2026-01-27",{"date":86,"type":87},"2026-01-30","ACTUAL",{"date":89,"type":69},"2026-02-01",{"date":91,"type":69},"2026-05-01",{"name":5,"class":6},1]