[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595673":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":56,"responsibleParty":75,"collaborators":77,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":31,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":107,"whyStopped":31,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Fundación Cardioinfantil Instituto de Cardiología","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"OCTAPLAS LG","EXPERIMENTAL","Pharmaceutical fresh frozen plasma (OCTAPLAS LG®), bolus dose of 10 mL\u002Fkg (max. 500 mL) administered over \\\u003C15 minutes",[13],"Biological: Pharmaceutical fresh frozen plasma",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal saline","ACTIVE_COMPARATOR","Bolus dose of 10 mL\u002Fkg normal saline (NS) (max. 500 mL) administered over \\\u003C15 minutes.",[19],"Drug: Normal Saline",{"label":21,"type":16,"description":22,"interventionNames":23},"Ringer Lactate","Bolus dose of 10 mL\u002Fkg Ringer's lactate (max. 500 mL) administered over \\\u003C15 minutes.",[24],"Drug: Ringer lactate (RL)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Pharmaceutical fresh frozen plasma","OCTAPLAS LG® has been registered with INVIMA in Colombia for five years and is used as a plasma replacement in cardiac surgery, hematologic diseases, or intensive care settings where blood bank plasma is unavailable",[9],null,{"type":33,"name":34,"description":17,"armGroupLabels":35,"otherNames":31},"DRUG","Normal Saline",[15],{"type":33,"name":37,"description":22,"armGroupLabels":38,"otherNames":31},"Ringer lactate (RL)",[21],[40],{"name":41,"affiliation":42,"role":43},"Philp Spinella Dr, MD","University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Jaime Fernandez Dr, PHD","CONTACT","+576016672727","73210","jfernandez@lacardio.org",{"name":52,"role":47,"phone":53,"phoneExt":54,"email":55},"Lorena Acevedo Dr, MsC","+57601672727","32002","gacevedo@lacardio.org",[57],{"facility":58,"status":31,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Fundacion CardioInfantil - Instituto de Cardiología","Bogotá","Bogota D.C.","111031","Colombia","CO",{"type":65,"coordinates":66},"Point",[67,68],-74.08175,4.60971,{"lat":68,"lon":67},[71],{"name":72,"role":47,"phone":73,"phoneExt":31,"email":74},"Lorena Acevedo, Msc","3103496080","lorenaacevedo@gmail.com",{"type":76,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[78],{"name":42,"class":6},"100595673","phase-4-randomized-control-study-in-resuscitation-of-sepsis-trial-100595673",false,"NCT07035509","Randomized Control Study in REsuscitation of SEpsis Trial","Randomized Control Study on Normal Saline vs Plasmalite vs Plasma in REsuscitation of SEpsis Trial (RESET) - A Feasibility and Comparative Study","RESET","Inclusion criteria\n\n* Age: ≥1 month (corrected gestational age) to 18 years.\n* Diagnosis of sepsis with at least one of the following conditions:\n* Signs of poor perfusion: prolonged capillary refill ≥2 sec, weak peripheral pulses, unexplained metabolic acidosis (base deficit \\> (-)5.0 mEq\u002FL), altered. mental status, lactate ≥2 mmol\u002FL (sample drawn without tourniquet use. (Appendix 2). OR\n* Systolic blood pressure (SBP) below the 5th percentile for age.\n* Signed informed consent from the patient's legal guardian.\n\nExclusion Criteria:\n\n* Receipt of ≥2 boluses of NS 0.9% or balanced solution in the last 24 hours for the current sepsis episode (bolus defined as ≥10 mL\u002Fkg (max. 500 mL) of NS\u002FRL given in \\\u003C30 min).\n* Known allergic reaction to plasma-derived products.\n* Known IgA deficiency.\n* Suspected or confirmed congestive heart failure.\n* Nephrotic syndrome.\n* Known chronic kidney disease with fluid overload or congestive heart failure.\n* Diagnosed hemorrhagic dengue fever confirmed by antigen or serology (NS1 or IgM positive).","ALL","4 Weeks","18 Years",{"count":91,"type":92},150,"ESTIMATED","INTERVENTIONAL",[95],"PHASE4","Crystalloids vs. Synthetic Plasma for Fluid Resuscitation in Children with Sepsis - REsuscitation of SEpsis Trial (RESET): A Comparative and Feasibility Study This research study, called the REsuscitation of SEpsis Trial (RESET), is a randomized clinical trial comparing crystalloids and synthetic plasma for fluid resuscitation in children with sepsis. Below, we explain some key aspects you should be aware of.\n\nWhat is a Clinical Trial? A clinical trial is a type of medical research designed to gather more information on how our bodies respond to medications or other treatments.\n\nMost new medical treatments must be evaluated in clinical trials before they can be approved by government agencies. These agencies ensure that new treatments are not only safe but also beneficial for patients-what medicine refers to as being \"safe and effective.\" If a new treatment has not yet been approved, it is considered \"experimental.\"\n\nResearchers analyze the results of multiple clinical trials to determine which medications work best and how they function. The advancement of medical science requires the participation of many people in numerous studies worldwide.\n\nWhat is the Purpose of This Study? This study evaluates whether Octaplas LG helps children and adolescents with sepsis and whether it improves the function of blood vessels inflamed due to infection. Sepsis occurs when an infection severely affects a person's health.\n\nOctaplas LG is a medication approved for use in Colombia. It is known as pharmaceutical plasma and is obtained from voluntary donors worldwide. It undergoes an ultra-detailed sterilization process using the most advanced techniques for processing blood derivatives. In medicine, fresh frozen plasma (FFP) is typically used, which is the equivalent of Octaplas LG but with far fewer industrial sterilization processes. These additional processes in Octaplas LG significantly reduce the risk of transmitting infections.\n\nAlthough Octaplas LG is approved by INVIMA, its use for fluid resuscitation has not yet been approved.\n\nThis study will compare Octaplas LG with normal saline solution and Ringer's lactate, which are commonly used for rehydrating patients. All three treatments will be administered in the same manner.\n\nWhy is My Child Being Asked to Participate?\n\nYour child is being invited to participate in this clinical study because:\n\nThey are receiving care in the pediatric intensive care unit (PICU). They are between one month and 18 years old. They have been diagnosed with sepsis and require fluid resuscitation. Your child's participation is voluntary. If you decide not to participate, your child will not lose any medical benefits. Your child's doctor has determined that they may be a good candidate for this study. You are free to discuss participation with your family, friends, or another physician.\n\nSome members of your child's healthcare team may also be involved in this research. They are dedicated to your child's care as well as the objectives of this study. However, you are not obligated to participate. If you choose to enroll your child, you will be asked to sign an informed consent form.\n\nHow Will My Child Be Assigned to a Treatment Group? Upon admission to the pediatric intensive care unit (PICU), if your child has a confirmed sepsis diagnosis and requires intravenous fluids or plasma to support heart function, they will be randomly assigned to one of the three treatment groups.\n\nRandomization is a research method used in clinical trials to assign patients to study groups in an unbiased way-similar to drawing numbers from a hat. Neither you, your child's doctor, nor the researchers will choose which group your child is placed in. Instead, a computer will randomly assign them to a group.\n\nTreatment Groups:\n\nGroup 1: Normal Saline (0.9% Sodium Chloride)\n\nYour child will receive the standard treatment for sepsis, including antibiotics, intravenous fluids, heart function monitoring, mechanical ventilation if needed, and blood pressure medications (vasopressors) if necessary.\n\nGroup 2: Ringer's Lactate\n\nIn addition to standard sepsis management, your child will receive Ringer's lactate, another commonly used resuscitation fluid in pediatric sepsis.\n\nGroup 3: Octaplas LG\n\nIn addition to standard sepsis management, your child will receive pharmaceutical synthetic plasma, which contains proteins and essential blood components that have undergone advanced processing to eliminate the risk of infectious disease transmission.\n\nHow Many Children Will Participate in This Study? At Fundación Cardioinfantil-Instituto de Cardiología, we are seeking the participation of approximately 150 children in this study.\n\nHow Long Will My Child Be in the Study? Your child will remain in their assigned treatment group for up to 28 days from PICU admission or until they no longer require intensive care hospitalization.",[98,99],"Septic Shock","Pediatric Critical Illness",[101,102,103,104,105,106],"sepsis","Septic shock","Fluid bolus","plasma","pediatric","crystalloids","NOT_YET_RECRUITING","2025-06-16",{"date":110,"type":111},"2025-06-25","ACTUAL",{"date":113,"type":92},"2025-07-01",{"date":115,"type":92},"2026-07-15",{"name":5,"class":6},1]