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Delirium clinical trials

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NCT ID: NCT02054169 Completed - Delirium Clinical Trials

Feasibility of the Modified Confusion Assessment Method for the Emergency Department (mCAM-ED)

Start date: August 2013
Phase: N/A
Study type: Observational

Delirium is common in older emergency department (ED) patients and often remains unrecognized. Existing instruments to detect delirium are often time consuming and therefore not feasible in the busy ED setting In this study the investigators tested the feasibility of the newly developed modified confusion assessment method (mCAM-ED).

NCT ID: NCT02045004 Completed - Dementia Clinical Trials

Cohort Study to Investigate the Association Between Changes in Brain Volume and Postoperative Cognitive Dysfunction

POCD-MRI
Start date: July 14, 2015
Phase:
Study type: Observational

Despite an ongoing controversy in the scientific literature, the link between anesthesia and dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an association of surgery with a reduction in brain volume. With the present prospective cohort study, we would like to reproduce and verify these results, and investigate a possible association with the postoperative cognitive performance. We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months after major non-cardiac surgery and determine cognitive functions at the same time. Study hypothesis: 1. Surgery under general anesthesia in elderly patients is associated with a loss of gray matter. 2. The degree of cognitive dysfunction is associated with the loss of grey matter in brain areas relevant for cognitive functions.

NCT ID: NCT02035436 Completed - Delirium Clinical Trials

Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Me-chanical Ventilation - Effects on Cognitive Function

Start date: January 2014
Phase: N/A
Study type: Interventional

Through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. However, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. The NONSEDA trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six ICUs in Denmark, Norway and Sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. This is a substudy of the NONSEDA trial, concerning 250 patients included at trialsite Kolding, Denmark. The aim of the substudy is to assess the effects of no sedation on delirium during admission and cognitive function after discharge from ICU. Our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have better cognitive function after discharge.

NCT ID: NCT02032030 Completed - Stroke Clinical Trials

Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys

SATISFY-SOS
Start date: July 2012
Phase:
Study type: Observational [Patient Registry]

Based on limited published epidemiological data, up to an alarming 1 in 50 surgical inpatients die within 30 postoperative days. Based on our own data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and 1-year mortality among high-risk surgical patients may be as high as 10%. Short- and intermediate-term postoperative mortality is therefore a pressing public health concern. Similarly, postoperative major morbidity - including delirium, stroke, myocardial infarction, atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia, respiratory failure, loss of functionality, and chronic pain - occurs commonly and affects a substantial proportion of surgical patients, critically ill patients and patients undergoing procedures for chronic pain. Many factors associate strongly and independently with postoperative mortality and major morbidity: patient age, functional status, comorbid medical conditions, and duration and invasiveness of surgery, among others. It is a strategic priority to identify pre- and intraoperative risk factors that are subject to modification.

NCT ID: NCT02028260 Withdrawn - Delirium Clinical Trials

Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

Start date: January 2014
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo controlled study of 30 patients. Patients who qualify, as per the inclusion criteria (RASS greater than -3, less then +1, CAM positive, present gastric access) will either be given 200mg of modafinil or an identical, indistinguishable placebo. The placebo and study drug will be distributed by the hospital pharmacy. Once enrolled, each patient will be reassessed every morning to determine appropriateness for drug administration. If the RASS is less than -3 (i.e. comatose) or greater then 0 modafinil will not be given. He/she will then be assessed each morning thereafter. Due to the stimulant-like actions of modafinil, the drug will be administered only in the morning. Patients will be assessed for delirium at least twice a day; trained personnel using the Confusion Assessment Method (CAM) will do the assessment. Qualification for a delirium free day will be no positive CAM screens for 24 hours following drug administration. Additional data such as days on mechanical ventilation and progression to tracheotomy will also be collected hypothesizing that patients who take modafinil will have a shorter time to extubation therefore avoiding the need for a tracheotomy. Post-discharge from the unit, but within 48 hours, patients will be asked to participate in a survey (The Richards-Campbell Sleep Questionnaire (RCSQ) assessing their perception of daytime and nighttime sleepiness in the intensive care unit as well as their overall perception of rest. Their functional capacity will also be evaluated at this time and compared to their pre-morbid baseline. The hypothesis tested is that Modafinil restores sleep cycle synchrony in the ICU therefore increasing delirium free days and improving ICU outcomes.

NCT ID: NCT02025855 Enrolling by invitation - Delirium Clinical Trials

Adjunct Methadone to Decrease the Duration of Mechanical Ventilation in the Medical Intensive Care Unit

Start date: January 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if administering methadone to mechanically ventilated patients in the medical intensive care unit (ICU) requiring continuous infusions of sedatives and analgesics will decrease the time of mechanical ventilation, when initiated within 48 hours of their admission. Patients meeting enrollment criteria will be randomly assigned to receive methadone or placebo in addition to standard care. Methadone is a long acting pain medication that is approved by the Food and Drug Administration (FDA) to manage withdrawal from opioids and moderate to severe pain. Both of these indications are a frequent concern for critically ill patients that require mechanical ventilation. These patients often require intravenous (IV) opioids to manage the pain they experience due to their illness, procedures, and mechanical ventilation. During this time patients can develop physical dependence, which leads to withdrawal symptoms when the opioids are stopped or the dose is reduced. These symptoms can include agitation, pain, diarrhea and several others. Currently this is managed by a slow reduction in the dose of the IV opioid, but this can lead to prolonged time on mechanical ventilation, which has been associated with increased morbidity. Administering oral methadone to patients experiencing withdrawal symptoms has been shown to reduce and even eliminate these symptoms in the outpatient setting. This should also benefit patients in the ICU experiencing withdrawal from intravenous opioids required during their stay. It may allow for the other opioids to be discontinued more quickly, allowing for a shorter duration of mechanical ventilation. The level of pain and sedation will be assessed between groups randomized to either methadone or placebo in addition to current intravenous sedative and analgesic agents. The duration of mechanical ventilation will be assessed between both groups. Opioid withdrawal symptoms may manifest or be mistaken for delirium symptoms. ICU delirium is often managed with antipsychotic medications. To assess if methadone can reduce the need for antipsychotic medication, all administered antipsychotic doses will be recorded and total consumption will be compared between the two groups. Methadone has been associated with abnormal heart rhythms in rare instances. To ensure patient safety, data from the heart monitor will be collected and compared between the two groups to assess for QT interval prolongation.

NCT ID: NCT02004665 Recruiting - Clinical trials for Acute Coronary Syndrome

Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study

Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

to evaluate the incidence of delirium in patients with acute coronary syndrome and its correlation with adverse events

NCT ID: NCT01998997 Completed - Delirium Clinical Trials

A Family Intervention for Delirium Prevention

Start date: March 2014
Phase: N/A
Study type: Interventional

To address the feasibility of implementing a randomized, educational intervention to prevent delirium, directed at family members of hospitalized older (70 years of age or older) medical in-patients. Specifically rates of recruitment and acceptance rates of such an intervention to family members will be assessed. An estimate of the effect size of this intervention will also be calculated. This is a pilot study. The investigators hypothesize that this intervention will be feasible and agreeable to family members to perform, with acceptance rates exceeding 80%.

NCT ID: NCT01993836 Completed - Clinical trials for Postoperative Delirium

Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care

MADCO-PC
Start date: November 2013
Phase: Phase 4
Study type: Interventional

This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.

NCT ID: NCT01983384 Completed - Delirium Clinical Trials

Anesthetic Depth and Postoperative Delirium Trial - 2

ADAPT2
Start date: July 2015
Phase: N/A
Study type: Interventional

Recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear.