Clinical Research Directory

CTSN Embolic Protection Trial

This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.

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

Pilot Clinical Trial of an Integrative Intervention to Improve Critically Ill Patients' Delirium and Related Outcomes

Methodology: Pilot randomized controlled trial with 1 intervention and 1 parallel standard care group to assess the feasibility and treatment effect of a multimodal integrative intervention for delirium prevention and associated detrimental effects. Duration: 2 years, two months. Study Center(s): Multi-center (2 sites) Aim: To assess feasibility and measures of effect of a multimodal intervention consisting of relaxation with guided imagery (RGI), and moderate pressure massage on physiological and psychological outcomes of critically ill patients. Objectives: a) assess clinical trial feasibility with pre-defined goals (enrollment, randomization, adherence, timing of intervention, workload), b) calculate estimates and variance of treatment effect across outcome measures, c) calculate confidence intervals (CI) of incidence proportions, means and standard deviation (SD) of outcome measures in study groups., d) explore underlying physiological mechanisms of efficacy Number of Subjects: 60 participants per arm. Total: 120 participants Diagnosis and Main Inclusion Criteria: Critical illness Inclusion criteria: a) Age over 18 years, b) ICDSC:0-3. Exclusion Criteria: Patients: a) with expected ICU LOS\< 72 hours, b) with acute neurological illness/ trauma, persistent sedation or coma, c) with current history of severe mental health problems and dementia, as per history and psychiatrist assessment, c) with hearing impairment or conditions not permitting use of headphones, e) on neuro-muscular blockers, f) with substance/ alcohol withdrawal, g) enrolled in trials of sedatives, antipsychotics. Intervention: REPOSE intervention (a multimodal relaxation intervention) It includes: a) relaxation and guided imagery (RGI) (40 min, headphones), b) a brief moderate pressure massage session (massage: 15 min). RGI involves: a) guided relaxation, b) a structured guided imagery script and c) music for 15 min (Mozart piano sonata KV283, G major (2 3) II Andante). Duration of administration: Up to 5 days while participants still in the ICU. Reference therapy: Standard care plus placebo to maintain blinding. Statistical Methodology: Outcomes will be analyzed longitudinally over 5 days by logistic regression model based on generalized estimating equations (GEE) with AR(1) correlation structure. Confidence intervals will be presented with estimated effects. Primary analysis will be based on all available data utilizing data from all assessments.

Delirium and EuroSCORE II in Cardiac Surgery

The goal of this observational study is to find out the association between EuroSCORE II of Delirium in patients undergoing cardiac surgery. The main questions it aims to answer are the incidence of Delirium in patients undergoing cardiac surgery and to find the association of EuroSCORE II with delirium in cardiac surgery patients.

Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

Delirium is a common complication following hip fracture surgery (HFS) in older people. Postoperative hypoxia has also been associated with delirium, but not specifically in geriatric patients. The aim of the study is to demonstrate that post-operative hypoxia is associated with in-hospital complications in patients with HFS.

Trazodone vs. Quetiapine for the Treatment of ICU Delirium

This is a single-center, prospective observational pilot study. The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine, in the management of ICU delirium in adult (\>=18 years old) surgical and medical ICU patients. The investigators will compare outcomes such as delirium duration, delirium-free days, coma-free days, in-hospital mortality, 28-day mortality, hospital length of stay (LOS), ICU LOS, mechanical ventilator days, complications, adverse effects, rescue medication use, delirium symptom severity, sleep duration, and sleep quality among participants receiving trazodone or quetiapine. The investigators hypothesize participants receiving trazodone will be associated with a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine.

Neurosteer Bedside Monitoring System

The purpose of this study is to evaluate the clinical utility of Neurosteer's brain monitoring platform for monitoring delirium, sedation, and agitation in intubated and sedated ICU patients. The research team will be conducting a single-site study. The research team will enroll 100 patients admitted to the NSICU. 50 of these patients will have Acute Neurological Injuries (ANI) and the other 50 will not have an ANI. All enrolled patients will receive the intervention, the Neurosteer brain monitoring device. The study intervention consists of the use of Neurosteer's innovative single-channel EEG monitoring device to determine if there is a good correlation and agreement between their signals/parameters to RASS, CAM-ICU, and continuous EEG monitoring readings. The Neurosteer device will be attached to their forehead and readings will be collected for the duration of their NSICU stay. The research team will adapt the current physical methods of detecting the depth of anesthesia i.e. through the Richmond Agitation-Sedation Scale (RASS) \& CAM-ICU, to auditory stimulation, which will be delivered through earphones with no physical contact, with the aim of achieving a high correlation between the methods. RASS and CAM-ICU will be collected hourly as standard of care and Neurosteer auditory stimulation will be done 3-4 times a day to coincide with RASS and 1-2 times a day to coincide with CAM-ICU. The research team will correlate collected hourly RASS and CAM-ICU assessments with Neurosteer derived signals and parameters.

RCT: Trazodone vs Quetiapine vs Placebo for Treating ICU Delirium (TraQ)

The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine and placebo, in the management of ICU delirium in adult (\>=18 years old) surgical ICU patients. The investigators will compare outcomes such as delirium incidence and duration, in-hospital mortality, 28-day mortality, hospital length of stay (LOS), ICU LOS, mechanical ventilator days, complications, adverse effects, rescue medication use, delirium symptom severity, sleep duration, and sleep quality among participants receiving trazodone, quetiapine, or placebo. The investigators hypothesize participants receiving trazodone will have a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine and placebo.

Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery

The investigation will establish biological plausibility and infrastructure required for a multisite clinical trial evaluating the re-purposing of fluvoxamine to mitigate postoperative delirium risk in geriatric patients undergoing non-cardiac non-intracranial surgery.

Older Adults With Cognitive Impairment Doing Sit to Stands, Walking in Transitional Care Programs: A Feasibility Study

The goal of this intervention study is to test the effects of a nurse-led mobility intervention (known as the OASIS Walking Intervention (Older Adults performing Sit to Stands and Walking Intervention)) in older adults with cognitive impairment, such as dementia, in transitional care programs. The main questions this study aims to answer are: * Is the study doable and are older adults satisfied with the intervention? * Does the intervention improve older adults' muscle strength, mobility, functional status and quality of life? Participants will be asked to do the following: 1. Be interviewed once so that a patient-centred communication care plan can be made 2. Do sit to stand activity 3. Walk as part of a walking program.

Low-dose Dexmedetomidine and Postoperative Delirium After Cardiac Surgery

Delirium is an acutely occurred and fluctuating cerebral dysfunction characterized with inattention, altered consciousness, cognitive decline and/or abnormal perception. It is common in the elderly after cardiac surgery and is associated with worse outcomes. Causes leading to delirium are multifactorial but sleep disturbances remains an important one. In previous studies, sedative-dose dexmedetomidine improves sleep quality in ICU patients with mechanical ventilation; and low-dose dexmedetomidine improves sleep quality in postoperative patients without mechanical ventilation. In recent studies of elderly after noncardiac surgery, night-time infusion of low-dose dexmedetomidine reduces delirium and improves 2-year survival. The investigators hypothesize that, for elderly patients after cardiac surgery, night-time infusion of dexmedetomidine may also improve sleep quality, reduce delirium development and improve 2-year survival.

Use of Pupillometry for Pain Assessment in ICU Patients With Delirium

Pain assessment in intensive care patients is a constant challenge. Approximately 50% to 80% of patients report pain at rest or during medical or nursing interventions (for example endotracheal suctioning, mobilization and rehabilitation, presence and care of invasive inputs, etc.). Obstacles to pain assessment and management are most often due to interference with communication due to impaired consciousness, airway support and connection to artificial pulmonary ventilation, or the effect of administered medication. Patients in intensive care are prone to delirium. Delirium can compromise patients' ability to verbalise pain for a variety of reasons (e.g. due to impaired attention, memory, thinking and language barriers). Also, pain and inadequate analgesia are risk factors for delirium. Pupillary reflex changes and their identification by automated pupillometry have yielded positive results regarding nociception assessment in adult and pediatric patients and in perioperative and postoperative care. At the same time, the response of these patients to opioid administration was investigated. The aim was to improve their analgesia. The aim of this study is to find out whether, there is an association between automated pupillometry and selected objective pain measurement scales in The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) positive patients after surgery.

TaVNS for Delirium

The goal of this clinical trial is to test whether a non-invasive device called transauricular vagus nerve stimulation (taVNS) is safe, practical, and potentially helpful for patients in the hospital who develop delirium. Delirium is a state of confusion that often happens to people in the hospital who are sick or hurt. It can cause agitation, trouble paying attention and difficulty understanding what is happening. Delirium may slow overall recovery. This study will focus on feasibility and safety. Researchers want to learn whether taVNS can be given safely to critically-ill patients, whether patients and staff can tolerate the treatments, and whether the device produces measurable changes in brain activity and brain oxygen levels. The main questions this study aims to answer are: * Is it possible to deliver taVNS safely and consistently to patients in the ICU who have delirium? * Do patients tolerate the device without significant side effects or complications? * Does taVNS cause short-term changes in brain signals and oxygen levels that may suggest effects on brain function? This is an early feasibility study and there is no randomization or placebo group. All patients enrolled will receive taVNS in addition to their usual hospital care for delirium. What participants will do: * Be identified by their hospital care team and have a confirmed diagnosis of delirium. * Provide consent (or have a legally authorized representative provide consent if the patient cannot.) * Undergo brief assessments of thinking and attention (for example, the ICDSC test.) * Receive taVNS treatment using a small clip electrode placed on the ear. * The device sends gentle electrical pulses to the nerve in the ear. * Each session lasts about 30 minutes, given twice per day (morning and evening, with at least 6 hours between sessions). * Treatment can continue for up to 7 days while the patient is in the ICU. * Be monitored during and after each session. The study team will check vital signs, examine the ear for irritation, and ask about any discomfort. * On the first day, researchers will also record brain signals (EEG) and brain oxygen levels before and during stimulation using FDA-approved hospital monitoring devices. Possible risks and discomforts: * Mild side effects are possible, such as tingling, a tickling or pricking feeling in the ear, or temporary skin redness where the clip is placed. * Serious side effects are not expected, but all patients will be closely monitored during and after each session to ensure safety. Possible benefits: • Patients may or may not experience personal benefit. The main benefit is helping researchers learn whether this treatment approach is safe and practical. In the future, taVNS could potentially become a new tool to help treat or prevent delirium in hospitalized patients. Study size and duration: * The study will enroll a limited number of ICU patients with delirium at Stony Brook University Hospital. * Patients may take part for up to 7 days while hospitalized. Who can join: * Right-handed, adult patients in the ICU who are diagnosed with delirium. * People with certain medical conditions (such as brain bleeds, new strokes, pacemakers or other contraindications) may not be able to participate, for safety reasons.

Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle

Patients frequently experience problems with sleep while admitted to the ICU. Good sleep is important in ensuring that your immune system responds properly to infection, for your heart to function optimally, and to support normal brain function such as memory. To address sleep problems in the ICU, a bundle of interventions to support more normal sleep are provided. These bundles consist of medications such as sedatives and environmental changes such as less frequent times being assessed overnight and noise reduction strategies. Although medications can make patients appear to be sleeping, most medications do not provide patients with restful sleep. More research is needed on medications that better mimick restful sleep. One such medication is dexmedetomidine. When formally measured dexmedetomidine can make sleep appear more like a patient sleeping at home as compared to the hospital. The purpose of this study is to test whether giving a patient in the intensive care unit dexmedetomidine helps have a more restful sleep and possibly be more alert and/or interactive the next day. To see if dexmedetomidine improves sleep, the investigators will compare the quality of sleep of two different groups of participants: one group that receives dexmedetomidine at night for 2 nights in a row and another group that does not. How well one sleeps will be measured, in either group, will be assessed by a portable sleep machine that is attached by several stickers. This study is called a pilot or feasibility study. A pilot study assesses how easy it is to recruit patients, whether the sleep machine is tolerated, and amount of time sleep is measured. It is anticipated that about 50 people will take part in this study. This study should take approximately 2 years to complete, and the results should be known in about 1-2 years thereafter.

Delirium and Neuropsychological Recovery Among Emergency General Surgery Survivors

This study will evaluate the usefulness of the Urgent and Emergency Surgery (UES) Delirium Recovery Model. It is hypothesized that the cognitive, physical and psychological recovery of older UES delirium survivors will be improved through the use of the DANE Recovery Model. Participants can expect to be on the study for 18 months.

PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients

Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.

Automating Delirium Severity in the ICU

The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients \>50 years of age. The main questions it aims to answer are: * Is the trained convolutional neural network able to reliably measure delirium severity. * Is the Passive Digital Marker able to accurately measure delirium severity * Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers). Participants will: * Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU). * Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.

Fecal Microbiota Transplantation for the Treatment of ICU Delirium

Delirium in the intensive care unit (ICU) is a prevalent and serious neurological complication among critically ill patients, with large multicenter studies reporting an incidence of 30% to 80%, particularly in those requiring mechanical ventilation. Delirium is not only associated with prolonged ICU and hospital stays but also with increased morbidity and mortality. Notably, up to 40% of survivors suffer from persistent cognitive dysfunction that may last for months or even years. Despite current standard pharmacological interventions-such as haloperidol and second-generation antipsychotics-failing to demonstrate significant clinical benefit in phase III trials, non-pharmacological strategies remain challenging to implement due to environmental and operational constraints within the ICU. This unmet clinical need underscores the imperative to develop novel, effective therapeutic approaches. Emerging evidence suggests that ICU-acquired gut microbiota dysbiosis plays a pivotal role in the pathogenesis of delirium. Dysbiosis can compromise intestinal barrier integrity, promoting systemic inflammation and increasing susceptibility to various forms of delirium, including acute illness-related and postoperative types. These effects are likely mediated through the "gut-microbiota-brain axis," which may represent a central mechanism underlying neurocognitive dysfunction in critical illness. Preclinical studies have demonstrated that fecal microbiota transplantation (FMT) can restore microbial balance and exert beneficial effects on neurological function. FMT has shown promise in ameliorating cognitive deficits in models of Alzheimer's disease, chronic cerebral hypoperfusion, traumatic brain injury, and chronic unpredictable mild stress (CUMS). Clinically, FMT has been associated with cognitive improvement in patients with dementia, recurrent Clostridioides difficile infection, and sepsis-associated encephalopathy. With expanding applications in both gastrointestinal and extraintestinal disorders, FMT has emerged as a transformative therapeutic modality, supported by robust short- and long-term safety and efficacy data. This study aims to evaluate whether FMT can alleviate delirium severity, correct gut microbiota dysbiosis at 0, 72, and 120 hours post-enrollment, attenuate intestinal barrier dysfunction, reduce systemic inflammation and disease severity, shorten ICU length of stay, and lower rates of ICU mortality, in-hospital mortality, and 28-day all-cause mortality-ultimately positioning FMT as a potential breakthrough intervention for ICU delirium.

Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery

The incidence of postoperative delirium in patients after cardiovascular surgery is very high, which seriously affects the short-term and long-term prognosis of patients, but its mechanism is not clear. Recent studies have found that lactic acid participates in the process of sepsis by inducing histone lactatation in macrophages. histone H3 lysine 18 lactylation (H3K18la) is significantly associated with the severity of disease and inflammatory response. Inflammation plays an important role in postoperative delirium. We therefore hypothesized that macrophage H3K18la also plays a role in postoperative delirium. At the same time, the latest literature shows that the early markers of Alzheimer's disease (AD), such as Aβ, exosomes and phosphorylated tau, etc. \[5\], can also be detected in the serum of AD patients. Given the obvious correlation between Alzheimer's disease and postoperative delirium \[6\], we hypothesized that serum biomarkers of AD could also be used as serum biomarkers for postoperative delirium. The objectives of this study were to investigate the correlation between H3K18 in serum monocytes and postoperative delirium and its severity in patients undergoing cardiovascular surgery. Meanwhile, we also detect the serum levels of biomarkers of AD, such as Aβ, tau and exosomes etc., in patients undergoing major cardiac surgery. We aim to find the serum biomarkers of delirium after major cardiac surgery, so as to provide a more convenient diagnostic basis for the prevention of postoperative delirium.

Delirium in Neurodegenerative Disease Patients: A Music Therapy Intervention for Hospital Care

In this pilot study a new kind of music therapy will be created and tested to help prevent confusion, called delirium, that can happen in the hospital. This can affect people with brain diseases like Alzheimer's disease and Parkinson's disease. Each of the anticipated 30 participants will have up to five music therapy sessions. The sessions will be made just for them and may include live music, playing instruments, or listening to recorded music. Surveys will be used to learn how easy the therapy is to do in the hospital and what people think about how helpful the sessions may be for future patients.

Perioperative EEG-Monitoring and Emergence Delirium in Children

Emergence delirium is a significant problem, particularly in children. However the incidence, preventative strategies, and management of emergence delirium remain unclear. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of emergence delirium in children under 16 years scheduled for elective surgery using electroencephalogram. The "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" (Sikich et al. 2004) is used to screen for the occurrence of emergence delirium in the post anesthesia care unit.

Perioperative EEG-Monitoring and Postoperative Delirium in Patients Undergoing Cardiovascular Surgery

Postoperative delirium is common in patients undergoing cardiovascular surgery and associated with poor outcomes. However the pathogenesis of postoperative delirium is poorly understood. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of postoperative delirium in patients undergoing cardiovascular surgery using electroencephalogram.

VR Interventions to Reduce the Prevalence of Delirium in ICU Patients

The goal of this clinical trial is to learn the effect of Virtual Reality Family Support System (VRFS) on reducing delirium in ICU mechanically ventilated patients. The main question it aims to answer is: ·Using VRFS for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes? Researchers will investigate whether the implementation of VRFS can reduce the number of delirium days and improve clinical outcomes. Participants will: * Receive the VRFS intervention until the endotracheal tube (ETT) is removed. * Have physiological data collected, including EEG, oxygen saturation levels, ECG, and blood pressure. * Keep a diary of delirium, dosage of sedative and analgesic drugs, the duration of mechanical ventilation, and ICU stays.

Bedside Bike Early Mobilization Program for Inpatients

Hospital immobility leads to serious complications including muscle loss, weakness, delirium, pressure ulcers, and blood clots. Despite being medically stable, hospitalized patients spend over 90% of their time in bed due to staffing shortages, fall risks, and limited physical therapy availability. Within one week of admission, patients can lose approximately 2% of thigh muscle mass per day, and nearly half develop clinically significant hospital-acquired weakness.The Bedside Bike is a portable, low-resistance exercise device that clamps securely to hospital beds, allowing patients to perform leg and arm cycling exercises safely without leaving their bed. This study will evaluate whether hospitalized patients at Indiana University Health facilities can feasibly and safely use the Bedside Bike to maintain mobility during their hospital stay.This quality improvement study will enroll 80 adult inpatients expected to stay at least 3 days. All participants will receive the Bedside Bike in addition to usual care (standard physical therapy and medical treatment). The study will measure how often patients use the device, whether it is safe (tracking any device-related problems), and whether it may help improve outcomes such as hospital length of stay, functional mobility scores, discharge to home, and rates of hospital-acquired weakness. Participants will have functional assessments at admission and discharge, use the Bedside Bike throughout their hospitalization (targeting at least 15 minutes daily), and be followed for 60 days after discharge to track readmissions, falls, living arrangements, and mortality.