[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"icu-delirium\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:icu-delirium":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,73,96,120],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100652983","abcdef-bundle-compliance-and-icu-outcomes-in-latin-america-100652983",false,"NCT07783035","ABCDEF Bundle Compliance and ICU Outcomes in Latin America","ABCDEF Bundle Compliance and Outcomes in Latin American Intensive Care Units: An International Multicenter Prospective Observational Study","Inclusion Criteria:\n\n* Age ≥18 years Admission to the ICU during the 3-month recruitment period\n* Expected ICU length of stay ≥48 hours\n* Written informed consent provided by the patient or legal representative (or eligibility for deferred consent according to local regulations)\n\nExclusion Criteria:\n\n* History of moderate to severe dementia\n* Severe chronic brain disease (e.g., previous disabling stroke, Parkinson's disease, advanced multiple sclerosis)\n* Severe prior intellectual disability or prior functional cognitive dependence\n* Palliative sedation scheduled from ICU admission\n* Deep irreversible coma or diagnosed brain death\n* Uncorrected bilateral deafness\n* Non-Spanish speakers\n* Refusal or explicit request by the family not to participate","ALL","18 Years",{"count":19,"type":20},580,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the degree of compliance with the ABCDEF bundle and its relationship with clinical outcomes in adult patients (aged 18 and older) admitted to intensive care units (ICUs) in Latin America for at least 48 hours.\n\nThe main questions it aims to answer are: What is the prevalence, cumulative incidence, and duration of delirium in adult ICU patients in Latin America? Is higher compliance with the ABCDEF bundle (low \\[\\\u003C33%\\], moderate \\[33%-66%\\], high \\[\\>66%\\]) independently associated with a lower prevalence, cumulative incidence, and duration of delirium? Does higher ABCDEF bundle compliance improve functional mobility at hospital discharge and long-term cognitive, psychological, and quality-of-life outcomes at 3 and 6 months post-discharge? Researchers will compare three groups based on their level of ABCDEF bundle compliance (low \\[\\\u003C33%\\], moderate \\[33%-66%\\], and high \\[\\>66%\\]) to see if higher bundle adherence improves delirium and long-term post-ICU functional outcomes.\n\nParticipants will:\n\nReceive standard ICU care without experimental intervention. Undergo daily assessments for delirium (using CAM-ICU) and physical mobility (using ICU Mobility Scale) during their ICU stay.\n\nComplete telephone follow-up evaluations at 3 months post-discharge to assess cognitive function (BCAT-ICU\u002FMoCA) and psychological symptoms (HADS, DSPS).\n\nComplete follow-up evaluations at 6 months post-discharge to assess cognitive function (full MoCA), psychological symptoms (HADS, DSPS), and health-related quality of life (EQ-5D-5L).",[24,25,26],"Icu Delirium","Post Intensive Care Syndrome","Critical Illness",[28,29,30,25],"ABCDEF Bundle","Delirium","Intensive Care","NOT_YET_RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-24","ACTUAL",{"date":34,"type":20},{"date":38,"type":20},"2026-11-30",{"name":40,"class":41},"Hospital H+ Queretaro","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100620941","phase-2-exogenous-ketone-supplementation-in-icu-delirium-100620941","NCT07364162","Exogenous Ketone Supplementation in ICU Delirium","Exogenous Ketone Ester Supplementation in ICU Delirium (KETONES ICU)","KETONES-ICU","Inclusion criteria:\n\n1. Adult patients (≥18 years old) admitted to the medical intensive care unit.\n2. Current ICU admission with anticipated ICU stay ≥24 hours.\n3. Enteral access in place, planned enteral access placement, or PO intake appropriate, and the ability to receive enteral dosing within 24 hours of enrollment.\n4. Ability to complete delirium assessments (CAM-ICU feasible) at time of enrollment.\n\nExclusion criteria:\n\n1. Severe metabolic acidosis at screening: blood gas pH \\\u003C7.20 or bicarbonate \\\u003C 8 mmol\u002FL.\n2. Diabetic ketoacidosis as an ICU admission diagnosis or hyperketonemia from any ketoacidosis state.\n3. Hypoglycemia as an ICU admission diagnosis or glucose \\\u003C60 mg\u002FdL.\n4. Patients with a history of type 1 diabetes mellitus.\n5. Hemoglobin \\\u003C7.0.\n6. Fulminant hepatic failure or International Normalized Ratio (INR) \\> 3, when not attributable to therapeutic anticoagulation or another clearly non-hepatic cause.\n7. Refractory shock, defined as a sustained norepinephrine requirement ≥30 µg\u002Fmin, or norepinephrine-equivalent vasopressor dose, despite appropriate resuscitation, or ongoing escalation of vasopressor support at the time of enrollment.\n8. Pregnancy (positive urine\u002Fserum hCG at screening or known pregnancy) or breastfeeding.\n9. Uncontrolled ileus or gastrointestinal condition, such as an upper gastrointestinal bleed, preventing enteral dosing.\n10. ADH\u002FALDH inhibitors (e.g., fomepizole, disulfiram) use in the prior 7 days or planned.\n11. Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE \\>4.5. This exclusion also pertains to mental illnesses requiring long-term institutionalization, acquired or congenital intellectual disability, severe neuromuscular disorders, Parkinson's disease, and Huntington's disease. It also excludes patients with severe deficits due to structural brain diseases such as stroke, intracranial hemorrhage, cranial trauma, malignancy, anoxic brain injury, or cerebral edema.\n12. Benzodiazepine dependency or alcohol dependency based on the medical team's decision to institute a specific treatment plan involving benzodiazepines or barbiturates (either as continuous infusions or intermittent intravenous boluses) for this dependency.\n13. Active seizures during this ICU admission being treated with intravenous benzodiazepines.\n14. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family\u002Fmedical team (e.g., likely to withdraw life support measures within 24 hours of screening).\n15. Admission to ICU only for post-operative monitoring or frequent neurologic assessments.\n16. Incarcerated status.\n17. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Attending physician refusal.\n18. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient and\u002For surrogate refusal.\n19. Inability to obtain informed consent within 24 hours from the time all inclusion criteria were met: Patient unable to consent and no surrogate available.\n20. Current enrollment in a study that does not allow co-enrollment.",{"count":51,"type":20},40,"INTERVENTIONAL",[54],"PHASE2","Delirium is a common syndrome in intensive care unit (ICU) patients. Those experiencing delirium may suddenly feel confused, have trouble thinking clearly, struggle to pay attention, or see and hear things that are not real. Delirium is associated with worse long-term outcomes such as cognitive impairment, depression, and PTSD (post-traumatic stress disorder). This study examines whether an investigational medical-grade ketone supplement drink (ketone monoester \\[brand name: Ultrapure Ketone Monoester\\]) is safe and feasible to use in ICU patients, and to look for signals that it might reduce delirium or shorten its duration compared to a volume-, taste-, and calorie-matched placebo.",[57,26],"ICU Delirium",[59,60,61,62,63],"ICU","Intensive Care Unit","Critical care","Critical illness","Ketones","RECRUITING",{"date":34,"type":35},{"date":67,"type":35},"2026-06-09",{"date":69,"type":20},"2027-12-31",{"name":71,"class":41},"Vanderbilt University Medical Center",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":52,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":72},"100429797","wheat-beer-for-prevention-of-delirium-in-intensive-care-patients-100429797","NCT04876742","Wheat Beer for Prevention of Delirium in Intensive Care Patients","A Randomised Placebo-controlled Double-blind Exploratory Trial Within Cohort Using Wheat Beer for Prevention of Delirium in Intensive Care Patients","BABE-D","Inclusion criteria\n\nAll Patients meeting the following criteria are eligible for the study:\n\n* Risk of delirium: ICU patients with expected length of stay (LOS) ≥ 24 hours\n* Naso-gastric tube in situ\n* ICU stay ≤ 72h until first study intervention\n* Women: negative pregnancy test, age ≥50 years or status post hysterectomy\u002Fbilateral ovariectomy\n* Adult patients (age ≥ 18 years)\n* ≥ 50 kg body weight or BMI ≥18.5\n\nExclusion Criteria\n\nPatients fulfilling the following criteria are excluded from the study:\n\n* Pre-existing liver pathologies\n* Patients after bone marrow transplantation\n* Women: breastfeeding\n* Pre-existing delirium (ICDSC ≥ 4)\n* Terminal state\n* Active psychosis\n* Anamnestic complete alcohol abstinence or status post alcohol abuse\n* Especially vulnerable patients\n* Allergy to any ingredient(s) of beer",{"count":82,"type":20},380,[84],"NA","The investigators hypothesise that the daily administration of 0.5L alcohol-containing wheat beer at 8 pm over a study period of 6 days in a row leads to a lower prevalence of delirium compared to water following the same administration scheme.",[57],"2026-06-10",{"date":89,"type":35},"2026-06-11",{"date":91,"type":35},"2023-01-18",{"date":93,"type":20},"2029-12-31",{"name":95,"class":41},"University Hospital, Basel, Switzerland",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":52,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":72},"100620420","virtual-reality-for-icu-delirium-prevention-100620420","NCT07357389","Virtual Reality for ICU Delirium Prevention","VR for ICU Delirium Prevention","Inclusion Criteria:\n\n* Individuals who are currently admitted to the SICU at Cedars-Sinai Medical Center\n* Expected ICU stay \\>48 hours\n* Richmond Agitation Sedation Scale (RASS) score between -1 to +2.\n* CAM-ICU negative\n* 1≤ risk factor for delirium (Age ≥ 65 years old, history of cognitive impairment, sepsis, Sequential Organ Failure Assessment (SOFA) score \\>5, history of alcohol or benzodiazepine abuse, recent major surgery)\n\nExclusion Criteria:\n\n* Unwilling and\u002For unable to participate\n* Intubation of tracheostomy\n* Self-reported history of severe motion sickness\n* Inability to follow commands (e.g. severe aphasia, deafness, GCS\\\u003C13)\n* The presence of a facial\u002Fhead deformity that will prohibit the wearing of a VR head mounted device (HMD\n* Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses\n* Having had a seizure in the past year\n* Unable to understand the instructions or to consent to participation in the study.\n* Those who are pregnant\n* Hemodynamic instability (MAP\\\u003C65 despite support)\n* End-of-life care\n* Severe agitation or delirium (i.e. CAM-ICU + screen)",true,{"count":105,"type":20},822,[84],"The purpose of this study is to evaluate whether daily exposure to immersive virtual reality (VR) can reduce the incidence of delirium in high-risk, non-intubated ICU patients. Participants will be randomized to either standard ICU care or standard care plus once-daily 15-minute VR sessions consisting of calming natural scenes, guided meditation, and music. The study population includes adult surgical ICU patients at Cedars-Sinai who are CAM-ICU negative at enrollment and possess at least one established risk factor for delirium. Outcomes will include the incidence and duration of delirium, ICU and hospital length of stay, feasibility of the VR intervention, and the frequency of adverse events. By targeting a high-risk population with an innovative non-pharmacologic therapy, this trial aims to generate data to support integration of VR into ICU delirium prevention protocols.",[57],[57,110],"Virtual Reality","2026-03-16",{"date":113,"type":35},"2026-03-17",{"date":115,"type":35},"2026-03-10",{"date":117,"type":20},"2028-04",{"name":119,"class":41},"Cedars-Sinai Medical Center",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":52,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":72},"100520304","modified-hospital-elder-life-program-at-intensive-care-unit-100520304","NCT06054828","Modified Hospital Elder Life Program at Intensive Care Unit","Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial","mHelp@ICU","Inclusion Criteria of the second phase\n\n* participants who are 18 years old or older.\n* participants who receive oral endotracheal intubation with mechanical ventilation and are expected intubation greater than 48 hours.\n* participants are free from delirium or coma before ICU admission.\n\nExclusion Criteria of the second phase\n\n* participants who are placed on droplet or contact precautions (e.g., Open TB, SARS, COVID-19 )",{"count":129,"type":20},266,[84],"Delirium, a form of acute brain dysfunction, occurs in up to 81% of patients receiving mechanical ventilation in the intensive care unit (ICU). Delirium occurring in the ICU is associated with increased functional dependency, cognitive impairment, longer length of hospital stay, and mortality. This study aim to develop a nursing-driven ICU delirium intervention to reduce incidence of delirium, increase the delirium-and coma-free days (DCFDs), and improve ICU patients' function, cognition, and mortality outcomes 3 months following their ICU admission. The \"modified Hospital Elder life Program at the ICU (mHELP@ICU)\" will be provided to ensure critically ill patients are cognitively engaged, physically active, and nutritionally well-fed.\n\nThis three-year study is divided into two phases. The first phase aims to ensure the accuracy of delirium assessment using the Intensive Care Delirium Screening Checklist (ICDSC) by ICU nurses of three participating ICUs. The ICDSC records assessed by ICU nurses will be abstracted from medical records and compared with a gold standard ICDSC evaluation by a well-trained, independent assessor. Cohen's kappa will be reported to represent the consistency of the ICDSC assessment between delirium data from medical records and the independent assessor. When the Cohen's kappa is less than 0.8, a 3-month bedside teaching and real-time feedback education program will be implemented at three ICU units to improve the accuracy of ICDSC assessment by ICU nurses. The second phase will be a clinical trial using a stepped-wedge cluster randomized controlled trial design. Adult (18 years and older) critically ill patients receiving mechanical ventilation will be consecutively enrolled from three mix-medical ICUs at a studied medical center. Estimated 266 participants will be cluster-randomized into the intervention and control groups. Participants in the intervention group will receive a 14-day mHELP@ICU, provided by a trained mHELP nurse, while the participants who received the usual care will serve as controls. Effects of mHELP@ICU will be evaluated using the daily delirium and coma data (max 14 days, or until death or ICU discharge) retrieved from the medical records, along with the participants' mortality, cognitive, and functional outcomes, which a blinded outcome assessor will assess at 48 hours, 14 days, 30 days, and 90 days after ICU admission.",[57],[29,134,135,136,137,138,139],"Intensive care units","Intervention","Mortality","Mobility","Cognitive function","Stepped-wedge cluster randomized controlled trial","2025-11-25",{"date":142,"type":35},"2025-11-28",{"date":144,"type":35},"2023-09-05",{"date":146,"type":20},"2026-07-31",{"name":148,"class":41},"National Taiwan University Hospital"]