[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573121":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":28,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":11,"enrollmentInfo":40,"targetDuration":11,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":11},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients received Ivabradine","ACTIVE_COMPARATOR",null,[13],"Drug: Ivabradine 5mg Tab",{"label":15,"type":16,"description":11,"interventionNames":17},"Patients didn't receive Ivabradine .","SHAM_COMPARATOR",[18],"Drug: control",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Ivabradine 5mg Tab","Ivabradine (5 mg twice daily) orally or via nasogastric tube",[9],{"type":21,"name":26,"description":15,"armGroupLabels":27,"otherNames":11},"control",[15],{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","RAMY AHMED","Assistant Professor of Anesthesia","100573121","role-of-ivabradine-for-heart-rate-control-in-management-of-patients-with-sepsis-and-septic-shock-100573121",false,"NCT06742164","Role of Ivabradine for Heart Rate Control in Management of Patients With Sepsis and Septic Shock","Inclusion Criteria:\n\n* Patients with proven or suspected site of infection.\n* Patients sepsis (acute organ dysfunction secondary to documented or suspected infection)\n* Patients with septic shock (defined as hypotension unresponsive to fluid resuscitation and requiring vasopressor treatment to maintain adequate blood pressure) for at least 6 hours and less than 24 hours.\n* Patients with sinus rhythm with heart rate ≥ 95 bpm at time of randomization. Informed consent obtained in accordance with local regulations.\n\nExclusion Criteria:\n\n* Cardiac arrhythmia, conduction disorder, sinus syndrome (\"sick sinus syndrome\"), atrial fibrillation and heart block.\n* Cardiogenic shock or acute heart failure, without proven or suspected infection.\n* Acute coronary syndrome.\n* Refractory shock with systolic arterial pressure \\\u003C90 mm Hg despite the use of high doses of vasopressors.\n* Co-treatment with drugs inducing bradycardia.\n* Patients with pacemakers.\n* Known pregnancy, breast-feeding, women with of childbearing potential will be tested for pregnancy and excluded if pregnant.\n* Known allergy to Ivabradine\n* Severe renal failure (creatinine clearance \\\u003C15 ml\u002Fmin) or hepatic failure (prothrombin time \\\u003C20%)\n* Tachycardia due to hyperthyroidism, pheochromocytoma or severe anemia (\\\u003C7 g\u002Fdl)\n* Enteral feeding impossible.","ALL","18 Years",{"count":41,"type":42},76,"ESTIMATED","INTERVENTIONAL",[45],"NA","Tachycardia is associated with excess mortality during septic shock. This may be related to the increase in cardiac metabolic demand, impaired cardiac diastolic function and less effect of administered exogenous catecholamines.\n\nIn this study, we evaluate the effect of enteral Ivabradine on outcome of septic patients regarding need for vasopressor therapy, mechanical ventilation, renal replacement therapy, length of ICU stay and in-hospital mortality.",[48],"Heart Rhythm Disorder","NOT_YET_RECRUITING","2024-12-16",{"date":52,"type":53},"2024-12-19","ACTUAL",{"date":55,"type":42},"2024-12-30",{"date":57,"type":42},"2025-06-30",{"name":5,"class":6}]