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120 active trials for Delirium

Effect of Intranasal Insulin on POD

Decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. Postoperative Delirium (POD) is an acute disturbance in attention, awareness and cognition. The cause of POD are not fully understood. Insulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. Animal study showed that insulin given via the nose (intranasal insulin) preserves memory function after exposing to anesthesia suggesting that intranasal insulin also could be a therapeutic option POD. This study is designed to examine the effect intranasal insulin on POD. The goal is to investigate whether administration of intranasal insulin during and after heart surgery reduces the incidence of POD.

Start: March 2019

Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium

Delirium is a frequently occurred cerebral complication in elderly patients after surgery, and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be one of the most important risk factors of postoperative delirium. Previous studies showed that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine infusion improved the quality of sleep and decreased the incidence of delirium. The investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine supplemented analgesia can also decrease the incidence of delirium, possibly by improving sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly patients after cancer surgery.

Start: January 2017

Postoperative Delirium in Cardiac Surgery ICU

Postoperative Delirium (POD) is a common complication in patients after cardiac surgery, which is associated with short-term prognosis and long-term quality of life. Due to the lack of specific treatment, prevention is the most effective strategy to reduce delirium. Risk assessment greatly contributes to guide prevention by stratifying the risk of the POD. However, the high-quality risk assessment tools are still sparse, and the combination of risk assessment and stratified prevention has not been applied to the management of delirium after cardiac surgery. In the previous work, we found the predictive value of preoperative cardiac function on POD, and found a critical value. On the basis of previous research, this project will learn from previous studies on risk factors of POD, and deeply explore potential predictors. Furthermore, we will develop and validate POD risk prediction model, and then develop it into a visual evaluation system. In addition, based on the theory of risk management and risk assessment tools, using the concepts and methods of evidence-based medicine, the risk assessment system and stratified management program of POD will be formed and evaluated by expert discussion meetings. It is expected that the risk assessment system and stratified management program constructed by this project could simply and quickly screen high-risk patients and carry out timely intervention, so as to reduce the incidence of POD, improve patients' prognosis and the quality of life after cardiac surgery.

Start: January 2021

Improving the Recovery and Outcome Every Day After the ICU

Primary Specific Aim: Determine the effect of the combined physical exercise and cognitive training on the cognitive function of ICU survivors aged 50 and older. Hypothesis: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher total index cognitive scores as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at 3 and 6 months post randomization. Secondary Specific Aim 1: Determine the effect of the combined physical exercise and cognitive training on physical performance, anxiety and depressive symptoms, and quality of life of ICU survivors aged 50 and older. Hypotheses: In comparison to older ICU survivors randomized to attention control or either intervention alone, those randomized to 12 weeks of combined physical exercise and cognitive training will have higher physical performance as measured by short physical performance battery (SPPB) and two-minute step test, lower mood and anxiety symptoms as measured by Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scale, and higher quality of life as measured by the Medical Outcomes Study 36-item short form (SF-36) at 3 and 6-months post randomization. Secondary Specific Aim 2: To examine the mechanisms of action of combined training. Hypothesis: At the completion of treatment, the combined intervention group will show reduced serum levels of CRP, IL-1, IL-6, IL-8, TNF-?, S-100?, and GFAP and increased levels of BDNF, VEGF, and IGF-1 compared to the attention control, or either intervention alone groups.

Start: September 2017

Dexmedetomidine to Reduce the Incidence of POCD After Open Cardiac Surgery

Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.

Start: August 2018

Neurocognitive Impairment in Pediatric Patients With Meningoencephalitis and Sepsis-associated Encephalopathy

Neurocognitive impairment is frequently observed in pediatric patients with meningoencephalitis (ME) and sepsis-associated encephalopathy (SAE) which represent two relevant central nervous system (CNS) diseases in pediatric patients. It is uncertain, if the the origin of the disease, located primarily in the CNS of patients with ME or secondarily in patients with SAE in the course of sepsis, is of importance for the severity of injury to the brain. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed in a comparative study. Biomarkers of neuroaxonal injury are therefore not only of great interest to detect and monitor neurocognitive impairment but also to quantify the severity of brain injury in patients with ME and SAE.

Start: August 2020

Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care

This phase II/IIII trial studies how well haloperidol and lorazepam work in controlling symptoms of persistent agitated delirium in patients with cancer that has spread to other places in the body undergoing palliative care. Haloperidol and lorazepam may help in controlling symptoms of agitated delirium in patients with cancer and may lessen any distress that their caregivers may be experiencing.

Start: July 2019

Effect of the Intra-abdominal Pressure on the Risk of Delirium in Mechanically Ventilated Patients.

intra-abdominal hypertension (IAH) and delirium are serious, high-frequency complications in intensive care unit (ICU) patients. The consequences of the complication range from high morbidity and mortality to a greater need for nursing care. We hypothesize that there could be a correlation between IAH and incidence of delirium.

Start: July 2016

Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)

The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients

Start: December 2017

Effect of Preoperative Intervention With Folic Acid and Vitamin B12 on Postoperative Neurobehavioral Changes in Children

Comparison of preoperative folic acid and VitB12 intervention on postoperative delirium and long-term neurobehavioral changes in children under general anesthesia

Start: June 2020

Cognitive Changes After Major Joint Replacement - Full Trial (Cognigram 2)

Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly reduces quality of life. Identifying risk factors for POCD is important because it is associated with prolonged hospital stay, loss of independence, and premature retirement. There is an urgent need to measure and document the level of cognitive change associated with surgery with an easy to use tool, both prior to admission and after discharge. This information can be used to plan appropriate care paths and to identify or test the efficacy of potential new treatments to alter the negative trajectory.

Start: May 2017

Illuminating Neuropsychological Dysfunction and Systemic Inflammatory Mechanisms Gleaned After Hospitalization in Trauma-ICU Study

Cognitive skills are essential to live independently, manage finances, maintain employment, and function in society. Loss of these cognitive skills puts a tremendous burden on society as seen with dementias, Alzheimer's disease, and traumatic brain injury. The INSIGHT-ICU Study (Illuminating Neuropsychological dysfunction and Systemic Inflammatory mechanisms Gleaned after Hospitalization in Trauma-ICU Study) is the first comprehensive and longitudinal long-term cognitive impairment study after traumatic injury. The societal impact of long-term cognitive impairment after trauma is immense given that these patients are young and constitute a large proportion of employable adults.

Start: November 2017

Improving Safety of Diagnosis and Therapy in the Inpatient Setting

To improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients, the investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement,and data analytics to thoroughly analyze the problem, design and develop potential solutions that leverage existing current technological infrastructure, and implement and evaluate the final interventions. The investigators will engage the interdisciplinary care team and patient (or their caregivers) to ensure treatment trajectories match the anticipated course for working diagnoses (or symptoms), and whether they are in line with patient and clinician expectations. The investigators will use an Interrupted time series (ITS) design to assess impact on diagnostic errors that lead to patient harm. The investigators will perform quantitative and qualitative evaluations using implementation science principles to understand if the interventions worked, and why or why not.

Start: April 2019

Tight End-tidal Gas Control During Anesthesia to Decrease Postoperative Delirium Anesthetic Management

Respiratory end-tidal gas control is a fundamental of anesthetic management. The range of end-tidal (ET) O2 and CO2 during the conduct of anesthesia is far outside that found in the awake state. Recent work has indicated that alterations in end-tidal gases may influence the incidence of postoperative delirium (POD). This study will examine the feasibility of tight end-tidal gas control during anesthesia to decrease the incidence of POD.

Start: June 2020

Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

B-FREE is a pragmatic, multicentre, cluster crossover trial evaluating whether a policy limiting the use of intra-operative benzodiazepine reduces post-operative delirium when compared with a policy of 'ad libitum' administration. The knowledge generated by this study will provide the basis for cardiac anesthesia practice guidelines.

Start: November 2019

Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy

The investigator will examine the safety, tolerability, optimal dose, and preliminary efficacy of dexmedetomidine sublingual film in a randomized, double-blind, controlled trial in 40 hospitalized patients with hyperactive delirium (i.e., delirium with agitation) in the Intensive Care Unit (ICU) setting. Specific Aim #1 (safety and tolerability): To examine the incidence of cardiovascular and other side effects following the administration of dexmedetomidine sublingual film in patients hospitalized in the ICU with delirium and agitation in a randomized, double-blind trial (total N=80 patients with delirium [with or without agitation], with a goal of administering dexmedetomidine to at least 40 participants with agitation). Hypothesis: Dexmedetomidine sublingual film will be associated with hypotension and/or bradycardia requiring clinical intervention in ? 20% (8 of 40) participants. Dexmedetomidine will not be associated with QTc prolongation or non-cardiac adverse events. Specific Aim #2 (preliminary efficacy): To examine the impact of dexmedetomidine sublingual film on agitation and delirium severity. Hypothesis: Dexmedetomidine will lead to reductions in agitation and delirium severity during the follow-up period (co-primary endpoints = 1 and 2 hours post-administration). Specific Aim #3 (optimal dosing): To identify the minimum dose that is effective at reducing agitation and delirium severity without causing significant side effects. Hypothesis: Participants receiving doses of 60 mcg of dexmedetomidine will have a faster time to a reduction in agitation and greater reductions in delirium severity than participants receiving 20 mcg of dexmedetomidine.

Start: June 2020

Post-surgical Delirium in Patients Undergoing Radical Cystectomy.

Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium occurs after major abdominal surgery may reach about 15% of the patients.(1) Aim The aim of this study is to determine the incidence of delirium after radical cystectomy surgery and the associated risk factors in Alexandria University hospital. Patients and Methods After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.

Start: October 2020

Post-surgical Delirium in Patients Undergoing Open Heart Surgery.

Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium occurs after open heart surgery may reach about 1/3 of the patients.(1) Aim The aim of this study is to determine the incidence of delirium after open heart surgery and the associated risk factors in Alexandria University hospital. Patients and Methods The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Start: October 2020

Effect of Minocycline on Delirium Incidence in Critically Ill Patients

Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).

Start: January 2020

Predicting the Risk of Post-operative Delirium: Use of Neuropsychology, Serum and CSF Biomarkers and Genetics to Predict Risk of Post-operative Delirium

The purpose of the study is to determine if pre-operative neuropsychological characteristics, apolipoprotein E4 status and/or cerebrospinal fluid (CSF) and serum biomarkers can predict those most at risk of post-operative delirium. Patients over the age of 65 years undergoing elective primary hip or knee arthroplasty in Musgrave Park Hospital are invited to take part. Participants undergo a pre-operative neuropsychological assessment which is repeated 6-12 weeks post-operatively at the time of surgical review appointment. At the time of surgery advantage is taken of the necessary venous cannulation and spinal anaesthetic to gain venous blood and CSF samples respectively. Venous blood is also sampled post-operatively. Patients are assessed daily for delirium, using the Confusion Assessment Method, until discharge.

Start: March 2012