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Delirium clinical trials

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NCT ID: NCT05474872 Recruiting - Clinical trials for Cognitive Impairment

Postoperative Delirium in the ICU Setting of an Eastern European Centre

Start date: July 15, 2022
Phase:
Study type: Observational

The study targets postoperative delirium in patients undergoing major abdominal surgery, with the aim to evaluate the functional baseline and proteomics implicated in pathogenesis, prevention strategies (such as anesthesia depth monitoring) and incidence in certain population groups.

NCT ID: NCT05470816 Recruiting - Dementia Clinical Trials

Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial

TRIGS-D
Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.

NCT ID: NCT05464355 Recruiting - Clinical trials for Cognitive Impairment

Biomarkers Associated With Postoperative Cognitive Dysfunction

Start date: January 5, 2023
Phase:
Study type: Observational

Loss of cognitive function after major surgery is a significant risk in older people. It can occur acutely in the days after surgery as delirium or in months to years later as a persistent reduction in brain function termed neurocognitive decline. Together these conditions are called post operative cognitive dysfunction (POCD). They can be acutely distressing for patients and are associated with other problems after surgery. The causes of post operative cognitive dysfunction are poorly understood. Studies have been limited by a lack of biomarkers to predict which patients are at high risk of developing POCD. Research suggests silent strokes occurring during surgery and different sensitivities to anaesthetic medicines are associated with POCD. The project consists of a feasibility study to investigate markers that might predict people over 65 years old getting POCD. The first biomarker is a non-invasive monitor of anaesthetics effects on brain function called electroencephalography (EEG): The investigators will identify which EEG patterns predict delirium within five days surgery. The second set of biomarkers are two blood tests of proteins that increase after strokes: these are neurofilament light chains and tau proteins. The investigators will establish if these can be used to predict having POCD up to one year after surgery and long term cognitive impairment up to 5 years after surgery.

NCT ID: NCT05461092 Recruiting - Delirium Clinical Trials

Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion

Start date: January 1, 2024
Phase: Early Phase 1
Study type: Interventional

This initial study is a feasibility study for implementing thoracolumbar interfascial plane, or TLIP, blocks in older adults undergoing spinal fusion. TLIP blocks are done by using anesthesia. In this case, it will be done to either side of the back where surgery will be performed. This has been shown to decrease pain the patients have post-operatively in previous research. In this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing TLIP. Further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. The ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of TLIP blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.

NCT ID: NCT05454228 Recruiting - Clinical trials for Postoperative Delirium

Biomarkers and Postoperative Delirium in Elderly Patients

Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

This study intends to verify and explore the correlation of neuroinflammation biomarkers in cerebrospinal fluid and plasma of elderly patients undergoing hip replacement with postoperative delirium, so as to achieve a new method to predict whether patients will develop postoperative delirium and improve the prognosis of elderly patients with postoperative delirium. Reduce the probability of postoperative complications, improve the long-term survival rate of patients after surgery.

NCT ID: NCT05442892 Recruiting - Delirium Clinical Trials

Use of Near Infrared Spectroscopy (NIRS) as a Biomarker of Delirium in Hospitalized Older Adults Doing Physical Exercise

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

Delirium is an important cause of morbimortality in older adults admitted to hospital. Multicomponent interventions targeting delirium risk factors, including physical exercise and mobilization, have been shown to reduce delirium incidence in 30-40% in acute care setting but little is known about its role in the evolution of delirium, once established. This study is a randomized clinical trial conducted in the Acute Geriatric Unit of a tertiary public hospital in Navarra, Spain. Hospitalized delirious patients who meet the inclusion criteria will be randomly assigned to the intervention or control group. The intervention will consist of a multicomponent exercise training programme, which will be composed of supervised progressive resistance and strength exercise training during 4 consecutive days. The objective is to assess the effectiveness of this intervention in reducing the following primary outcomes: duration and severity of delirium, functional status, and length of stay. This study will contribute to determine the usefulness of physical exercise in the management of delirium. It will be the first study to evaluate the impact of a multicomponent intervention based on physical exercise in the evolution of delirium.

NCT ID: NCT05437458 Recruiting - Parkinson Disease Clinical Trials

Parkinson's Disease: Risk Assessment of Persistent Delirium and Its Management

PARADIGM
Start date: February 6, 2022
Phase:
Study type: Observational

Background: delirium describes the change in people's behaviour and thinking when they are unwell. People with delirium may appear confused, have difficulty with organisation and can be different to their usual personality. Older people with Parkinson's are particularly susceptible to persistent delirium, which can last over 14 days. They are more likely to need increased community support and they have a greater risk of death and dementia. However, there is limited research for people with Parkinson's on how to effectively manage persistent delirium and how to identify those at risk of persistent delirium. Community support may not sufficiently support the care needs of people with Parkinson's, and this is expected to be more detrimental for people also affected by persistent delirium Study Design: retrospective case note review with qualitative interviews. Study participants: older people (≥65 years old) with Parkinson's disease, previously affected by either persistent delirium or another form of delirium (e.g. hyperactive, hypoactive, mixed). 207 participants with Parkinson's for quantitative data collection. The qualitative study will include up to 10 participants with Parkinson's from the quantitative part of this study. An additional maximum of 10 more carers for people with Parkinson's may also be interviewed. Research Aims: 1. To develop and estimate the assessment tool's sensitivity and specificity to predict persistent delirium in older people with Parkinson's in the outpatient setting. Persistent delirium in this study will be initially defined as a delirium lasting ≥14 days. An associated secondary objective will be to develop a scoring system that allocates an increasing number of points to risk factors that have a stronger association for predicting delirium. 2. To evaluate the management strategies used for persistent delirium. 3. To determine what are the community care needs for people recovering from persistent delirium.

NCT ID: NCT05436964 Recruiting - Delirium in Old Age Clinical Trials

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery

Start date: June 27, 2022
Phase: N/A
Study type: Interventional

To observe the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium, postoperative analgesic drug requirements and pain scores in elderly patients undergoing major abdominal surgery.

NCT ID: NCT05429749 Recruiting - Hip Fractures Clinical Trials

Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Start date: July 30, 2020
Phase: Phase 4
Study type: Interventional

This is a clinical trial to evaluate the effect of intravenous iron supplement with Ferinject (Ferric Carboxymaltose) in preventing postoperative delirium after hip fracture surgery.

NCT ID: NCT05403268 Recruiting - Critical Illness Clinical Trials

The EARLY DELTA Trial

EARLY DELTA
Start date: March 2, 2022
Phase: N/A
Study type: Interventional

Rationale: Delirium is a type of acute encephalopathy that is triggered by an underlying somatic disorder. Patients experience disturbances in attention, alertness and other cognitive functions. In patients with delirium, a characteristic electroencephalography (EEG) pattern is seen, known as polymorphic delta activity. The MDR certified medical device "Deltascan" can detect this EEG pattern. Traditional clinical delirium screening instruments are known to have limited sensitivity, in particular for detecting hypoactive delirium. We hypothesize that adding EEG based encephalopathy detection to clinical observation scales increases the sensitivity and results in earlier detection of delirium and subsyndromal delirium, resulting in improved clinical outcomes of critically ill patients, such as delirium duration, ICU length of stay or survival. Objective: This randomized controlled trial aims to study the effect of implementation of EEG based encephalopathy detection (DeltaScan, Prolira, Utrecht, The Netherlands, hereafter: DeltaScan) on relevant clinical endpoints (ICU length of stay, sedative requirements and delirium related complications, among others) in a mixed medical and surgical intensive care unit population. Study design: a randomized controlled trial Study population: adult patients (>18 years) admitted to the ICU for unplanned care with a minimal anticipated ICU length of stay of 48h. Intervention: either usual care, where the patients' medical team obtains regular delirium screening, versus usual care plus twice daily DeltaScan measurements. During the daily medical rounds, the DeltaScan results will be presented to the patients' medical team together with decision support, consisting of DeltaScan trend interpretation and protocol-based suggestions for evaluation of underlying delirium cause. Main study parameters/endpoints: primary endpoint will be ICU length of stay. Secondary endpoints are encephalopathy/delirium occurrence, ICU encephalopathy/delirium free days, ventilator free days, organ support free days, sedative, opioid and antipsychotic drug requirement, delirium related complication occurrence, frequency and duration of physical restraints application, ICU mortality, ICU readmission, hospital length of stay, hospital mortality and 90-day mortality. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, it is not expected that randomization to the intervention group adds risk for patients. This is a study of a diagnostic intervention with additional encephalopathy/delirium observations consisting of a short (90 seconds) EEG measurement, which does not harm the patient. Clinicians will receive protocol-based decision support alongside the diagnostic observation. No additional medical treatments will be conducted as part of the study protocol.