[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587932":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"First Affiliated Hospital of Wannan Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ciprofol group","EXPERIMENTAL","Patients in this arm will receive Ciprofol, an investigational sedative, administered via continuous intravenous infusion.\n\nDosing Protocol:\n\nInitial Dose: 0.1 mg\u002Fkg loading dose over 1-2 minutes. Maintenance Dose: 0.05-0.3 mg\u002Fkg\u002Fh, adjusted hourly based on the Richmond Agitation-Sedation Scale (RASS) score (target range: -3 to 0).\n\nCombined Analgesia:\n\nAll patients will concurrently receive remifentanil (0.05-0.3 μg\u002Fkg\u002Fmin) for pain control.\n\nMonitoring \\& Adjustments:\n\nSedation depth assessed every 30 minutes using RASS and ( Critical-Care Pain Observation Tool) CPOT scores.\n\nDose adjustments made to avoid hypotension (Mean Arterial Pressure) MAP \\\u003C 65 mmHg or oversedation.\n\nTriglyceride levels monitored daily to guide lipid emulsion management.\n\nSafety Measures:\n\nRescue protocol for hypotension (e.g., vasopressors) or respiratory depression (e.g., temporary ECMO flow adjustment).",[13],"Drug: Ciprofol",{"label":15,"type":16,"description":17,"interventionNames":18},"Midazolam group","ACTIVE_COMPARATOR","Patients in this arm will receive midazolam, a benzodiazepine sedative commonly used in ECMO patients, administered via continuous intravenous infusion.\n\nDosing Protocol:\n\nInitial Dose: 0.05 mg\u002Fkg loading dose over 2-5 minutes. Maintenance Dose: 0.02-0.1 mg\u002Fkg\u002Fh, adjusted hourly based on the RASS score (target range: -3 to 0).\n\nCombined Analgesia:\n\nAll patients will concurrently receive remifentanil (0.05-0.3 μg\u002Fkg\u002Fmin) for pain control, identical to the Ciprofol group.\n\nMonitoring \\& Adjustments:\n\nSedation depth assessed every 30 minutes using RASS and CPOT scores, consistent with the experimental group.\n\nDose adjustments made to avoid hypotension (MAP \\\u003C 65 mmHg) or oversedation. Daily monitoring of drug accumulation markers (e.g., midazolam plasma levels if available).\n\nSafety Measures:\n\nRescue protocol for hypotension (e.g., vasopressors) or respiratory depression (e.g., ventilator support escalation).",[19],"Drug: Midazolam",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ciprofol","Continuous intravenous infusion (0.05-0.3 mg\u002Fkg\u002Fh), adjusted hourly based on the RASS score (target range: -3 to 0).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Midazolam","Continuous intravenous infusion (0.02-0.1 mg\u002Fkg\u002Fh), adjusted hourly based on the RASS score (target range: -3 to 0).",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Qiancheng Xu","CONTACT","86-18297529106","qianchengxu@wnmc.edu.cn",{"type":38,"investigatorFullName":33,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100587932","phase-4-ciprofols-impact-on-oxygenator-function-in-extracorporeal-membrane-oxygenation-ecmo-patients-100587932",false,"NCT06934811","Ciprofol's Impact on Oxygenator Function in Extracorporeal Membrane Oxygenation (ECMO) Patients","Evaluating the Impact of Ciprofol on Oxygenator Performance in Patients Undergoing Extracorporeal Membrane Oxygenation: A Single-Center Randomized Controlled Trial (CIP-OXY Study)","CIP-OXY","1. Inclusion Criteria:\n\n   * Receiving ECMO therapy with an anticipated duration exceeding 72 hours;\n   * Requiring invasive mechanical ventilation;\n   * Requiring sedation and analgesia treatment.\n2. Exclusion Criteria:\n\n   * BMI \\>45 kg\u002Fm²;\n   * Age \\\u003C18 years;\n   * Severe hepatic (Child-Pugh Class C) or renal failure (eGFR \\\u003C15 mL\u002Fmin\u002F1.73m²);\n   * History of severe psychiatric disorders;\n   * Pregnancy;\n   * Refusal to sign informed consent;\n   * Contraindications to midazolam and propofol use.","ALL","18 Years","75 Years",{"count":52,"type":53},30,"ESTIMATED","INTERVENTIONAL",[56],"PHASE4","This study evaluates the safety and effectiveness of Ciprofol, a new sedative, in critically ill patients receiving Extracorporeal Membrane Oxygenation (ECMO), a life-support system for heart or lung failure. The investigation aims to:\n\nAssess how Ciprofol affects the oxygenator, a critical ECMO component responsible for adding oxygen to blood.\n\nCompare the safety of Ciprofol to midazolam, a commonly used sedative. Eligibility Criteria Adults aged 18 years or older. Patients receiving ECMO and mechanical ventilation for over 72 hours. Individuals requiring sedation for medical procedures. Study Protocol\n\nParticipants will be randomly assigned to one of two groups:\n\nCiprofol Group: Initial sedation dose of 0.1 mg\u002Fkg, adjusted as needed. Midazolam Group: Initial sedation dose of 0.05 mg\u002Fkg, adjusted as needed. Both groups will receive pain management with remifentanil. Sedation levels will be adjusted daily by the clinical team to ensure patient safety and comfort.\n\nOutcome Measures Primary: Oxygenator performance (oxygen and carbon dioxide levels) on Days 3 and 7.\n\nSecondary: Changes in blood triglyceride and clotting marker (D-dimer) levels, oxygenator lifespan before replacement, and safety outcomes such as low blood pressure, respiratory issues, or allergic reactions.\n\nSignificance ECMO patients often require prolonged sedation, but current sedatives like midazolam may contribute to oxygenator damage. Ciprofol's potential for faster recovery and fewer side effects could improve sedation practices and device longevity in this high-risk population.",[59,60,61,62,63],"ECMO Treatment","ARDS (Acute Respiratory Distress Syndrome)","ECMO and Acute MI","Respiratory Failure Patients Treated With ECMO","Shock, Cardiogenic",[23,65,66,67,68,28,69],"ECMO","Oxygenator function","Sedative","Randomized Controlled Trial","Oxygenator thrombosis","NOT_YET_RECRUITING","2025-04-12",{"date":73,"type":74},"2025-04-18","ACTUAL",{"date":76,"type":53},"2025-05-01",{"date":78,"type":53},"2026-12-31",{"name":5,"class":6}]