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Delirium clinical trials

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NCT ID: NCT04355195 Recruiting - Delirium in Old Age Clinical Trials

Quality Contract: Prevention of Postoperative Delirium in the Care of Older Patients (QV-POD-2)

Start date: April 20, 2020
Phase:
Study type: Observational

The project "QV-Delirium" is based on the decision of the Federal Joint Committee (G-BA) from 2017. The aim is to improve inpatient care for older patients who are undergoing inpatient surgery and thus to specifically reduce the postoperative risk of delirium. This is achieved through the implementation of evidence-based and consensus-based measures to prevent postoperative delirium in a comprehensive structured concept in routine care. The transparent documentation in an electronic patient file enables the relationships between the symptoms to be depicted in accordance with the clinical circumstances and the genesis of the postoperative delirium to be recorded and treated at an early stage.The independent Institute for Quality Assurance and Transparency in Health Care (IQTIG) receives the elements predefined (e.g. incidence of delirium) by IQTIG with which the quality is measured. The content of the additional elements from the routine data (see primary and secondary outcome measures) is merged internally and with BARMER and other health insurance data for a joint evaluation. Subproject 1: Preoperative evaluation of systolic and diastolic heart function in patients of the QV delirium cohort: In this process, this subproject relates to the evaluation of patients during the premedication visit. During the visit, an evaluation of the heart function using TTE should also take place in order to be able to evaluate later whether there is a association between the preoperative cardiac function examined and the development of postoperative delirium. The parameters to be collected are for the systolic heart function (LVEF, TAPSE, rest LV-SV and SVI, LVCO, LVCI LV / RV index, as well as for the diastolic dysfunction according to current recommendations (Nagueh SF et al., 2016) : MV DecT, MV E / A ratio, E'lat, E'sept, E ', E / E', IVRT-LV, S ', A', LAVI, tricuspid valve flow in tricuspid valve insufficiency: TR V max. Subproject 2 starts in April 2022: Anonymous quantitative employee (nurses and doctors) survey on the content of the quality contract with regard to employee satisfaction, feasibility, effectiveness, efficiency (cost-benefit balance), acceptance, needs, quality of the introduction, quality of the implementation.

NCT ID: NCT04341350 Recruiting - Clinical trials for Prevention of Delirium

Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation

INASED
Start date: August 6, 2020
Phase: N/A
Study type: Interventional

The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.

NCT ID: NCT04335968 Recruiting - Orthopedic Surgery Clinical Trials

Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients

DELIRLESS
Start date: January 23, 2021
Phase: Phase 3
Study type: Interventional

Postoperative delirium (POD) is one of the most frequent complications after surgery in elderly patients, affecting between 20 and 40% of patients older than 60 after major surgery. This complication has huge consequences for the patients, families and society: increase of morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs. Among numerous risk factors identified, perioperative inflammatory stress is a key element in delirium genesis: surgical trauma releases danger signals in systemic circulation, activating immune cells and leading to neuroinflammation. Melatonin is a neurohormone regulating circadian rhythm. But it also exhibits antioxidant and free radical scavenger properties, and regulates energy metabolism and immune function. It has already demonstrated a neuroprotective potential in various animal models. Its use against delirium is promising: it decreases delirium incidence in elderly patients hospitalized in medical ward, and several studies are now recruiting in ICU. The hypothesis of the trial is that in a high-risk population, perioperative melatonin can reduce the incidence of POD. The main objective is to evaluate the effect of perioperative melatonin administration on postoperative delirium incidence in the first 10 days after surgery, in elderly patients (over 70 years old) being hospitalized and scheduled for acute surgery of fractured lower limb (from femoral head to tibial plateau). This is a prospective, national multicentric (24 centers), phase III, superiority, comparative randomized (1:1) double-blinded clinical trial with two parallel arms: Experimental group: melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery. Control group: placebo of this drug with the same schedule, during the same period of time. The patients are aged 70 or older, hospitalized and scheduled for surgery of a severe fracture of a lower limb (from femoral head to tibial plateau).

NCT ID: NCT04320082 Recruiting - Delirium Clinical Trials

Alteration of Blood-Brain-Barrier Permeability at Loss of Consciousness in Delirious Patients Recorded With Direct-Current Electroencephalography (ACDC)

Start date: August 10, 2020
Phase:
Study type: Observational

With this trial we aim to characterize the intraoperative signatures of the Direct-Current-Electroencephalogram (DC-EEG) of elderly patients developing a PostOperative Delirium (POD) compared to patients who do not develop a POD. We hereby intend to gain a better understanding of the electrical potential at the blood-brain-barrier (measured with DC-EEG) during general anaesthesia. Second, we want to study the effect of age on the DC-EEG by comparing a younger (18-30y) to an elderly cohort (>70). Third, we aim to couple the DC-EEG signatures to blood sample analysis in order to understand the relationship between metabolic, inflammatory and vascular reaction with the intraoperative DC-EEG.

NCT ID: NCT04312893 Recruiting - Delirium Clinical Trials

The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

Start date: March 12, 2020
Phase: N/A
Study type: Interventional

Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium. Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score <30, Intensive Care Delirium Screening Checklist (ICDSC) >4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.

NCT ID: NCT04305600 Recruiting - Critical Illness Clinical Trials

Bringing to Light the Risk Factors And Incidence of Neuropsychological Dysfunction in ICU Survivors, 2nd Study

BRAIN-2
Start date: October 1, 2020
Phase:
Study type: Observational

This BRAIN-ICU-2 study [Bringing to light the Risk factors And Incidence of Neuropsychological dysfunction (dementia) in ICU Survivors, 2nd Study] is in direct response to PAR-17-038 and will determine ICU patients' main paths to decline, maintenance, or recovery of brain function. We will answer gaps in knowledge about long-term outcome of post-ICU brain disease by following the remaining ICU survivors from the original BRAIN-ICU-1 study with complete cognitive testing for the first time ever to 12 years (AIM 1). We will consent and enroll 567 new ICU patients at Vanderbilt and Rush Universities (i.e., BRAIN-ICU-2 cohort) and determine how detailed neuroimaging and cerebrospinal fluid samples can help reveal locations and mechanisms of injury beyond what we learned from the clinical information collected in our original study (AIM 2). Importantly, we are mirroring the existing world-renowned Rush Alzheimer's Disease Research Center brain bank program so that all patients enrolled in Aims 1 and 2 will able to donate their brains to science for the first-ever in-depth pathological study of those who do and do not get post-ICU dementia to define this disease formally (AIM 3)

NCT ID: NCT04289142 Recruiting - Delirium Clinical Trials

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

CODEX
Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04250610 Recruiting - Clinical trials for Postoperative Delirium

Survey Assessing the Level of Knowledge of Postoperative Delirium in Poland.

PODinPOL
Start date: February 27, 2020
Phase:
Study type: Observational

Postoperative Delirium (POD) is one of the most common complications occurring after surgery with an incidence ranging from 4 to 53%. It may lead to increased postoperative morbidity and mortality, with loss of independence and cognitive dysfunction in certain groups of patients. Aiming to reduce the incidence of POD and improve the outcome of patients diagnosed with POD, it is necessary to raise awareness regarding POD. The most important issue are: identification of risk factors, improved monitoring, necessary prevention and adequate treatment. The Polish Society of Anaesthesiology and Intensive Therapy (PTAiIT) has made an attempt to improve the situation in Poland by testing the implementation of official POD guidelines published by the European Society of Anesthesiology in year 2017. While the guidelines provide recommendations for daily practice it is necessary to identify the degree of their implementation in each country. Therefore survey has been prepared regarding postoperative delirium in Poland. This Survey has been submitted to the Bioethical Committee of the Pomeranian Medical University in Szczecin (Poland) and received a waiver due to the non-interventional, observational character of the study (decision no. KB-0012/06/01/2020/Z).

NCT ID: NCT04217915 Recruiting - Analgesia Clinical Trials

A Survey of Management of Analgesia, Sedation and Delirium in ICU Patients in China

SASE
Start date: July 12, 2021
Phase:
Study type: Observational

In 2018, the severe medicine branch of the Chinese Medical Association and the American Society of severe medicine successively updated the pain and sedation guidelines for severe patients (PADIS guidelines). In addition to the update of the original evaluation and management of pain and sedation and delirium, the new guidelines also increased the monitoring and management of early activities and sleep quality for severe patients. Therefore, it is necessary for us to investigate the compliance of the new guidelines for analgesia, sedation and delirium management among the medical staff of critical care, so as to find out the existing problems in the management of analgesia, sedation and delirium in critical care patients, and find solutions to improve the overall quality level of our management of critical care patients

NCT ID: NCT04195204 Recruiting - Clinical trials for Postoperative Delirium

A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac Surgery

Start date: November 1, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.