Covid 19 Research using Clinical Trials (Home Page)
Report for D003693: Delirium NIH
(Synonyms: Deliriu, Delirium)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3043 | Valproate Wiki | 0.50 |
| drug176 | Allocetra-OTS Wiki | 0.50 |
| drug2327 | Quetiapine Wiki | 0.50 |
| drug1583 | Local standard of care Wiki | 0.50 |
| drug1942 | OT Guided Cognitive Interventions Wiki | 0.50 |
| drug875 | Dexmedetomidine Injectable Product Wiki | 0.50 |
| drug703 | Colchicine Wiki | 0.16 |
| drug2698 | Standard of Care Wiki | 0.09 |
Correlated MeSH Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D020196 | Trauma, Nervous System NIH | 0.50 |
| D000071257 | Emergence Delirium NIH | 0.50 |
| D001927 | Brain Diseases NIH | 0.25 |
| D007249 | Inflammation NIH | 0.10 |
| D016638 | Critical Illness NIH | 0.07 |
| D011024 | Pneumonia, Viral NIH | 0.06 |
| D013577 | Syndrome NIH | 0.05 |
| D055371 | Acute Lung Injury NIH | 0.05 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.05 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.03 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001298 | Encephalopathy HPO | 0.25 |
| HP:0002090 | Pneumonia HPO | 0.03 |
There are 4 clinical trials
Clinical Trials
1 Guided Occupational Therapist Cognitive Interventions in Critically Ill Patients
Title: Guided Occupational Therapist (OT) Cognitive Interventions for Critically Ill Patients Short Title: GOTCI Methodology: Randomized Control Trial Study Duration: 12-15 months Study Centre: Single Center - South Health Campus, ICU, Calgary, Alberta, Canada Objectives: The aim for this study is to evaluate the effect of specific OT guided cognitive interventions on delirium in adult critically ill patients. Number of Subjects: 112 Primary Outcome: Delirium Prevalence and Duration Secondary Outcomes: Cognitive function, physical function, quality of life, ICU length of stay, hospital length of stay and days of mechanical ventilation. Inclusion Criteria: Adult Critically Ill Patients admitted to South Health Campus ICU, Calgary, Alberta Type of Intervention: OT guided cognitive intervention based on RASS score Dose: One on one therapeutic sessions with an OT. Five days a week, Monday to Friday, between 0800-1600. There will be twice daily sessions for 20 minutes each. Duration of administration: Cognitive Therapy to be initiated Monday to Friday, for the duration of participant ICU admission. Reference therapy: Standard of care within the Department of Critical Care Medicine in Calgary is delirium prevention strategies using the ABCDEF bundled approach. Statistical Methodology: Descriptive statistics (mean, median, proportion) will be employed to describe the study population. The primary outcome of delirium prevalence will be explored using multivariable logistic regression, which will provide an estimate of the odds ratio and accompanying 95% confidence intervals. Both per protocol and intent to treat analyses will be performed.
NCT03604809 Delirium Other: OT Guided Cognitive Interventions MeSH:Delirium
Primary Outcomes
Description: Ever Delirium: Measured using the Intensive Care Delirium Screening Checklist (ICDSC). If the patient has a positive score in the ICDSC at any point during the patient's ICU stay then the patient is considered to have delirium and qualifies for Ever Delirium. Delirium Duration: Number of days the patient has a positive score on the ICDSC. This does not have to be consecutive days.
Measure: Delirium Prevalence and Duration Time: From date of patient enrolment to ICU discharge, an average of 6.7 days.Secondary Outcomes
Description: Johns Hopkins Adapted Cognitive Exam (ACE) o The Adapted Cognitive Exam is the first valid and reliable examination for the assessment and quantification of cognition in critically ill patients. It provides a useful, objective tool that can be used by any member of the interdisciplinary critical care team to support clinical assessment and research efforts.
Measure: Cognitive Function Time: Measured within 24 hours of patient ICU admission and again after the treatment period is completed which is an average of 6.7 days.Description: Dates will be obtained from electronic medical charts. I.e. Sunrise Clinical Manager.
Measure: ICU length of stay Time: ICU admission date to ICU discharge date is the time the patient will be given the treatment which is an average of 6.7 days.Description: The Functional Status Score for the ICU (FSS-ICU). The Functional Status Score for the ICU (FSS-ICU) is an assessment of physical function specifically designed for ICU patients. It is scored based on 5 mobility domains (rolling in bed, lying to sitting, sitting balance, sitting to standing and walking) and the level of assistance the patient requires to complete the task. Each item is out of 7, with total scores ranging from 0-35 and a high score correlating to high function. The FSS-ICU has good validity when compared to other functional measures in the ICU, it has been demonstrated to have good interrater reliability and has minimal floor and ceiling effect.
Measure: Physical Function Time: Measured within 48 hours of ICU admission and again after the treatment period is completed which is an average of 6.7 days.Description: The 5 Level EQ 5D version is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal (Van Reenan & Janssen, 2015). It covers five dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression which are measured with one of five response options (no problems, slight problems, moderate problems, severe problems, and extreme problems). A total of 3125 possible health states is defined in this way. Each state is referred to in terms of a 5 digit code. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression (Reenan & Janssen, 2015, p. 9). The EQ5D-5L also includes a visual analog scale to measure health state (0-100).
Measure: Quality of Life using the EQ5D-5L (EuroQual 5 Dimensions-5 Levels). This is a health quality of life measure assessing five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Time: Measured after the treatment period is completed (within 24 hours of discharge) which is an average of 6.7 days.Description: Dates will be obtained from electronic medical charts. i.e. Metavision
Measure: Days of Mechanical Ventilation Time: Measured on day 1 of mechanical ventilation through to day of extubation (cessation of mechanical ventilation), an average of 4 days.Description: Date of hospital admission and discharge will be obtained from electronic medical chart. i.e. Sunrise Clinical Manager.
Measure: Length of Hospital Stay Time: Up to 6 months2 Impact of Dexmedetomidine Infusion on the Time Course and Outcomes of Acute Respiratory Distress Syndrome (ARDS) in Patients Affected by the SARS-CoV-2 (COVID-19) Admitted to Critical Care Unit
A continuous infusion of Dexmedetomidine (DEX) will be administered to 80 patients admitted to Critical Care because of signs of Respiratory Insufficiency requiring non-invasive ventilation. Measurements of respiratory performance and quantification of cellular and molecular inflammatory mediators. The primary outcome will be the avoidance of mechanical ventilation with secondary outcomes duration of mechanical ventilation, avoidance of delirium after sedation and association of mediators of inflammation to outcomes. Outcomes will be compared to a matched historical control (no DEX) series
NCT04358627 Acute Respiratory Distress Syndrome Inflammation Dexmedetomidine Cytokine Storm Delirium, Emergence Drug: Dexmedetomidine Injectable Product MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Delirium Emergence Delirium Syndrome Inflammation
Primary Outcomes
Description: (Presence/Absence) requirement of mechanical ventilation
Measure: Mechanical ventilation Time: expected within first three days (non conclusive due to lack of evidence yet)Secondary Outcomes
Description: Duration of mechanical ventilation if it is required (hours from the start)
Measure: Duration of mechanical ventilation Time: expected within first seven days (non conclusive due to lack of evidence yet)Description: Delirium criteria as defined in DSM-4
Measure: Delirium on recovery from sedation Time: First 24 hours after retiring dexmedetomidine sedation3 Biomarker-guided Assessment of Neurocognitive Impairment in Patients With COVID-19 - a Multicenter Case-control Study
Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.
NCT04359914 Critical Illness COVID-19 Central Nervous System Injury Delirium Encephalopathy MeSH:Delirium Brain Diseases Trauma, Nervous System Critical Illness
HPO:Encephalopathy
Primary Outcomes
Description: Assessment of neurocognitive impairment using validated tools
Measure: Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 Time: Day 90
Description: Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples
Measure: Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline biomarker levels at day 28
Description: Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Day 90
Description: Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline IQCODE results at day 90
Secondary Outcomes
Description: Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]
Measure: Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge Time: Day 90
Description: Cumulative days in hospital
Measure: Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 Time: 1 year
Description: Survival after 90 days
Measure: 90-day survival in patients with COVID-19 compared to patients without COVID-19 Time: Day 90
4 A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium
Primary Outcomes
Description: Assessment of neurocognitive impairment using validated tools
Measure: Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19 compared to patients without COVID-19 Time: Day 90Description: Measurement of biomarker levels (e.g. NSE, S100B, neurofilament proteins) derived from blood samples
Measure: Change in neuroaxonal injury biomarker levels in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline biomarker levels at day 28Description: Assessment of the neurocognitive performance of patients using validated tests (e.g. Short Blessed Test)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Day 90Description: Assessment of the change in the neurocognitive performance of patients using validated tests (e.g. IQCODE)
Measure: Neurocognitive 3-months outcome in patients with COVID-19 compared to patients without COVID-19 Time: Change from baseline IQCODE results at day 90Secondary Outcomes
Description: Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]
Measure: Quality of life in patients with COVID-19 compared to patients without COVID-19 after hospital discharge Time: Day 90Description: Cumulative days in hospital
Measure: Length of hospital stay in patients with COVID-19 compared to patients without COVID-19 Time: 1 yearDescription: Survival after 90 days
Measure: 90-day survival in patients with COVID-19 compared to patients without COVID-19 Time: Day 90The primary purpose of this research is to determine whether Valproate alone, and in combination with Quetiapine, lowers confusion and agitation in persons with severe Corona Virus Disease (COVID)19 pneumonia during weaning from the breathing machine (ventilator). Though Valproate and Quetiapine are often given to persons with severe confusion with agitation, the purpose of this small research study is specifically for: a) persons infected with COVID 2019 on a ventilator whose agitation is not responding to the usual medications (like dexmedetomidine), and b) to reduce the time persons are treated with dexmedetomidine, which requires continuous close monitoring in an ICU.
NCT04513314 Covid19 Hyperactive Delirium Pneumonia, Viral Drug: Valproate Drug: Quetiapine Other: Standard of Care MeSH:Pneumonia, Viral Pneumonia Delirium
HPO:Pneumonia
Primary Outcomes
Description: Richmond Agitation Sedation Scale (RASS) score ranges from +4 (combative) to 0 (alert & calm) to -5 (unarousable).
Measure: Change from baseline RASS score of +3 or greater Time: Baseline, Day 7
Secondary Outcomes
Description: Total dose of dexmedetomidine administered will be reported from baseline RASS score of +3 or greater.
Measure: Total dose of dexmedetomidine administered Time: Day 7
Description: Incidence of Treatment Emergent Adverse Events will include:
QTc duration > 470 msecs.
Increase in Liver Function Tests to a Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Suicidality reported as having a score of moderate or high risk using the Columbia-Suicide Severity Rating Scale Screening (C-SSRS). C-SSRS is a calculated risk assessment tool that scores suicidality from no risk to high risk.
Measure: Incidence of Treatment Emergent Adverse Events Time: Day 7
HPO Nodes
Primary Outcomes
Description: Richmond Agitation Sedation Scale (RASS) score ranges from +4 (combative) to 0 (alert & calm) to -5 (unarousable).
Measure: Change from baseline RASS score of +3 or greater Time: Baseline, Day 7Secondary Outcomes
Description: Total dose of dexmedetomidine administered will be reported from baseline RASS score of +3 or greater.
Measure: Total dose of dexmedetomidine administered Time: Day 7Description: Incidence of Treatment Emergent Adverse Events will include: QTc duration > 470 msecs. Increase in Liver Function Tests to a Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Suicidality reported as having a score of moderate or high risk using the Columbia-Suicide Severity Rating Scale Screening (C-SSRS). C-SSRS is a calculated risk assessment tool that scores suicidality from no risk to high risk.
Measure: Incidence of Treatment Emergent Adverse Events Time: Day 7