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Delirium clinical trials

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NCT ID: NCT02597231 Completed - Delirium Clinical Trials

Melatonin and Sleep in Preventing Delirium in the Hospital

MELO
Start date: November 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).

NCT ID: NCT02594982 Completed - Delirium Clinical Trials

DANish DELIrium Study On Neurointensive Care Patients

DANDELION
Start date: August 2015
Phase: N/A
Study type: Interventional

Abstract Background Studies have shown that delirium in medical and surgical intensive care units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium in the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment Method for the ICU (CAM-ICU). Aims 1. To measure the effect of a systematic intervention (sedation, sleep, mobilization and pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU. 2. To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method The design of the study is a two-phase interventional trial. Based on a power calculation, 56 patients will be enrolled both in the baseline and the intervention group (n=112). Part 1: A baseline investigation will be conducted to establish prevalence, duration and type of delirium symptoms in patients with acute acquired brain injury before implementing the intervention bundle. Part 2: A systematic Intervention protocol will be implemented in the N-ICU. The Intervention elements consist of a sedation, sleep, mobilization and pain treatment regimen based on the newest available evidence. Enrolled patients will be contacted 12 months after discharge for a follow-up including a quality of life with (EuroQoL-5D) questionnaire, a cognitive test measuring their cognitive end point (Repeatable Battery for Assessment of the Neuropsychological Status) and a short test for dementia symptoms (MMSE, Mini Mental State Examination).

NCT ID: NCT02591589 Active, not recruiting - Delirium Clinical Trials

Intraoperative Oxygen Concentration and Neurocognition After Cardiac Surgery

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

This is a randomized, prospective controlled trial in patients undergoing cardiac surgery, specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen and partial pressure of arterial oxygen in the operating room and its impact on a widely-used and validated neurocognitive score, the telephonic Montreal Cognitive Assessment (t-MoCA), throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It is hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the intraoperative period will have better neurocognitive function than those with maintenance of hyperoxia.

NCT ID: NCT02590796 Completed - Dementia Clinical Trials

Validating Studies to Assess the Diagnostic Accuracy of a Software Application for Detection and Monitoring of Attentional Deficits in Delirium

Start date: October 12, 2015
Phase:
Study type: Observational

The study has two phases: Phase B and Phase C. The purpose of the Phase B study is to determine the performance (sensitivity and specificity) of a smartphone application (DelApp) to identify delirium in the whole inpatient sample. The study also aims to determine the performance (sensitivity and specificity) of the DelApp to discriminate between delirium (with or without dementia) and dementia (without delirium). The purpose of the Phase C study is to determine the efficacy of the DelApp software application in detecting delirium in unselected patients in an inpatient sample and to determine the performance of the DelApp to discriminate between delirium and dementia. The study also aims to explore the performance of the DelApp in tracking change in cognitive function.

NCT ID: NCT02588742 Terminated - Delirium Clinical Trials

The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

Start date: February 2, 2015
Phase: N/A
Study type: Interventional

Delirium in older patients is associated with increased mortality and health care costs. And delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the most important risk factor for developing delirium. In this study, investigators will investigate the effect of administration of melatonin on postoperative delirium in elderly ICU patients. Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening from the day before surgery to the the 5th postoperation day. In contrast, patients in the control group are given placebo. Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC (Intensive Care delirium Screening Checklist). And secondary outcome includes intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood pressure, total amount of sedatives, total amount of analgesics, duration of mechanical ventilation, duration of ICU stay. Thus, investigators perform this study to investigate the relationship between delirium and circadian rhythm.

NCT ID: NCT02587039 Completed - Clinical trials for Coronary Artery Disease

An Intervention to Reduce Delirium After Cardiac Surgery

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

Patients that have cardiac surgery may suffer from unrecognized cerebral ischemia or loss of blood flow to the brain temporarily during surgery. This temporary loss of blood flow to the brain may result in a condition called delirium. Delirium is a type temporary confusion. There are some strategies that can help reduce cerebral ischemia during cardiac surgery which can help lead to a reduction in the incidence of delirium. The investigator believes that a strategy called remote ischemic preconditioning will help to reduce the incidence of delirium incidence after cardiac surgery. Remote ischemic preconditioning is a brief exposure to ischemia. This brief exposure to ischemia occurs in an area of the body that is not undergoing a procedure. This brief exposure to ischemia is not long enough to cause any damage to the body and it has been demonstrated to help protect against more severe ischemic injury that may occur later during surgery. In this study the investigator will use remote ischemic preconditioning to see if it can reduce the incidence delirium after cardiac surgery.

NCT ID: NCT02585128 Completed - Clinical trials for Postoperative Delirium

Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Start date: September 2015
Phase: N/A
Study type: Interventional

Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium. Acute neurocognitive dysfunctions are associated with adverse outcomes in these population. The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.

NCT ID: NCT02574234 Completed - Delirium Clinical Trials

Influence of Apelin Levels on Postoperative Cognitive Disorders After Orthopedic Surgery in Elderlies (APOCOGNIT)

APOCOGNIT
Start date: March 30, 2016
Phase: N/A
Study type: Interventional

No successful strategy is proposed to patients submitted to important surgery to reduce the incidence of postoperative cognitive disorders (POCD) onset. This project propose to measure plasma levels of apelin in wide population submitted to orthopedic surgery. Apelin could be involved in anti-inflammatory processes. Apelin levels before and after surgery correlated to postoperative cognitive disorders symptom measured by PET-Scan could be an important predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative cognitive disorders.

NCT ID: NCT02564939 Recruiting - Delirium Clinical Trials

Ramelteon Prevention of Delirium - RCT

Start date: February 23, 2017
Phase: Phase 4
Study type: Interventional

Delirium is a common morbid condition in hospitalized adults. Treatment of delirium has been unsatisfactory and prevention is the preferred goal. Based on limited experimental research, ramelteon appears to have promise for prevention. This study will evaluate ramelteon in prevention of delirium in a hospitalized adult population age 65+ in a double-blinded RCT.

NCT ID: NCT02558777 Completed - Delirium Clinical Trials

Pilot Study of a Multicomponent Nurse Intervention to Reduce Delirium in Hospitalized Older Adults

MID-Nurse-P
Start date: October 2013
Phase: N/A
Study type: Interventional

Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and severity of delirium in hospitalized older adults in an AGU. Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU "Complejo Hospitalario Universitario from Albacete" (Albacete, Spain). Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29 control group). Interventions: After risk factor analysis, all participants in the intervention group (IG) received a daily multicomponent intervention (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the intervention nurses. The control group (CG) received usual care. Measurements: Delirium presence was determined daily with the Confusion Assessment Method (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days of hospitalization, use of physical restraint measures, and use of drugs for delirium control (neuroleptics and benzodiacepines) were also recorded.