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Delirium clinical trials

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NCT ID: NCT01902277 Completed - Delirium Clinical Trials

ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region

Start date: June 2012
Phase: N/A
Study type: Observational

ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these. The purpose of this study was to determine the impact of ICU delirium in terms of both patients and beds. The study was carried out prospectively, over a one-week period, at adult ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).

NCT ID: NCT01901588 Active, not recruiting - Strabismus Clinical Trials

Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

Start date: March 2012
Phase: Phase 4
Study type: Interventional

This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

NCT ID: NCT01876355 Not yet recruiting - Delirium Clinical Trials

The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients

CATAPRES
Start date: January 2024
Phase: Phase 3
Study type: Interventional

Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that this therapy is effective and safe. Objective: The objective of this study is to compare the effect of clonidine with placebo on the occurrence and duration of delirium in mechanically ventilated ICU patients. Study design: Prospective randomised double-blind placebo controlled intervention study in 115 patients. Study population: All patients >18 years old, intubated mechanically ventilated and sedated at inclusion. Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen. Comparison: NaCl 0,9 % infusion as placebo. Main study parameters/endpoints: The main study parameter is the total number of awake and delirium-free observation periods the first 7 days after randomisation. An observation period is a nursing shift of 8 hours.

NCT ID: NCT01862302 Completed - Clinical trials for Postoperative Confusion

Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

HALPCARD
Start date: August 2013
Phase: Phase 3
Study type: Interventional

Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?

NCT ID: NCT01838733 Recruiting - Clinical trials for Myocardial Infarction

Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery

Start date: April 2014
Phase: N/A
Study type: Observational

Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the association between desaturations and perioperative outcome, and the mechanistic explanations of cerebral desaturations remain unexamined. This study seeks to identify the true incidence and magnitude of cerebral desaturations in high-risk non-cardiac surgical patients and the association between desaturations and perioperative outcome. The investigators will attempt to determine the following (1) The proper definition, incidence and severity of decreased cerebral saturation (rSO2) in high-risk non-cardiac surgical patients (2) the mechanisms surrounding decreases in rSO2 by correlating it with alterations in physiologic parameters (such as blood pressure, cardiac output, hemoglobin concentration, and carbon dioxide levels) and (3) to correlate the incidence and severity of decreased rSO2 with relevant perioperative. The investigators will also analyze a panel of inflammatory biomarkers to determine if these biomarkers have the ability to predict postoperative complications. The investigators will study 200 high-risk patients undergoing high-risk non-cardiac surgery. The investigators will determine the incidence and severity of decreases in rSO2, the associated factors with the occurrence of decreased rSO2, and the relationship between decreases in rSO2 and adverse perioperative outcome with a composite of well defined perioperative complications such as death, myocardial infarction, cerebrovascular accident, acute kidney injury, delirium, postoperative infections, and the need for mechanical ventilation.

NCT ID: NCT01836302 Completed - Septic Shock Clinical Trials

Septic Shock and Delirium Because of rSO2 Abnormalities in Intensive Care Unit Patients (The SAD BRAIN Study)

Start date: August 2012
Phase: N/A
Study type: Observational

Delirium in the ICU is a prevalent problem occurring in up to 80% of ICU patients. A potential cause of delirium in ICU patients could be cerebral hypoxia. Septic shock is associated with high rates of delirium. The aim of this pilot study is two fold. First, to determine the feasibility and potential challenges of measuring cerebral oxygenation in ICU patients with severe sepsis and septic shock. And second, to see if the incidence and magnitude of cerebral desaturations correlated with ICU acquired delirium as measured by the Confusion Assessment Method (CAM) scores.

NCT ID: NCT01827501 Completed - Delirium Clinical Trials

Avoidance of Delirium in Older Patients After Major Non-cardiac Surgery

ADOM
Start date: April 2013
Phase: N/A
Study type: Interventional

This study is designed to compare the incidence of postoperative delirium in older patients after major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group and a control group

NCT ID: NCT01816685 Completed - Delirium Clinical Trials

Effect of CPAP on Postoperative Delirium

Start date: June 2013
Phase: N/A
Study type: Interventional

Patients with a medical condition known as obstructive sleep apnea may be at increased risk of delirium following surgery. This study loans autotitrating CPAP machines to randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of preventing post-operative delirium.

NCT ID: NCT01811459 Completed - Delirium Clinical Trials

Trial Comparing Haloperidol, Quetiapine and Placebo in the Pharmacological Treatment of Delirium

Haloquet
Start date: February 2013
Phase: Phase 3
Study type: Interventional

Background: Delirium is an important problem in critical care. Its prevalence often reaches 75% in intensive care patients. Its occurrence is associated with numerous complications and deleterious consequences such as death, longer stay, higher cost, and long-term cognitive impairment. Delirium treatment entails correcting its underlying causes and usually initiating a pharmacological intervention with an antipsychotic. Typical antipsychotics, particularly haloperidol, are commonly used to treat delirium although few placebo-controlled trials of pharmacological treatments for delirium have been conducted. Furthermore, appropriate doses for delirium treatment have yet to be established. In critical care, two pilot studies provided the first randomized, placebo-controlled evidence for the pharmacologic treatment of ICU delirium. One found that neither haloperidol nor ziprasidone significantly reduced the incidence or duration of delirium compared with placebo whereas the other one found that quetiapine added to as-needed haloperidol resulted in faster delirium resolution. Objective: The goal of this study is to determine the effectiveness of antipsychotics in regular dosage regimen (quetiapine group and haloperidol group) compared to as-needed haloperidol (placebo group) in the pharmacological treatment of delirium. We will conduct a three-arm randomized controlled trial to achieve this goal. Materials and Methods: During one year, 45 delirious patients from three intensive care units will be recruited and randomized into one of three groups. Randomization will be performed in blocks of 9 by the pharmacy department, using a random numbers table. Patients will be continuously screened for delirium using the Intensive Care Delirium Screening Checklist (ICDSC) as part of routine care. A positive screening score (≥4) will warrant confirmation of delirium diagnosis by the treating physician. Treatment will begin according to randomization group, provided that informed consent has been obtained. Delirium status will be monitored during the episode using the Nursing Delirium Screening Scale (Nu-DESC). When the Nu-DESC monitoring will become negative for delirium (total score below 2), the resolution of the episode will be confirmed by the treating physician. A clinical evaluation by a psychiatrist will be performed within 24-48 hours of each of the two evaluations made by the treating physician (beginning and end of the delirium episode). The treating physician will initiate twice-daily treatment at the first of five levels for each of the three groups: 1) 1 mg of intravenous (IV) haloperidol + oral (PO) placebo, 2) 50 mg of PO quetiapine + IV placebo, or 3) IV + PO placebo. Therapy will be titrated upwards on a daily basis by increments of 1) 1 mg of IV haloperidol or 2) 50 mg of PO quetiapine, or 3) IV + PO placebo every 12 hrs, respectively, if the subject received at least two doses of as-needed haloperidol in the previous 24 hrs. As-needed (PRN) doses of 2 mg of IV haloperidol q 30 minutes will be available to patients from all three groups and administered by nurses until symptoms associated with delirium resolve. In case of unsuccessful as-needed treatment, rescue (STAT) doses of 5 mg of IV haloperidol q 30 minutes will be available to patients from all three groups and will be administered by nurses if agreement is reached with the treating physician that the situation indeed calls for it. The treatment level of patients requiring a STAT dose will immediately be raised to the above level. The treatment will stop when one of the following occurs: (1) the subject is deemed by the treating physicians, based on their clinical judgment, to no longer demonstrate signs of delirium and, therefore, to no longer require scheduled therapy with an antipsychotic agent; (2) 21 days of therapy has elapsed; (3) ICU discharge occurred; or (4) a life-threatening adverse event potentially attributable to the study drug occurred that warranted discontinuation of the study drug. Adverse effects will be closely monitored: extrapyramidal reactions, neuroleptic malignant syndrome, drowsiness, hypotension, QTc prolongation. The treatment level of patients presenting a non life-threatening adverse event will immediately be lowered to the level directly below. The sample size was calculated for a 2-tailed test with an alpha of .05 and a power of .80. The primary statistical analysis will involve Cox proportional time to event analysis comparing the three groups. Secondary analysis will use T-test comparisons for continuous variables and chi square for proportional analysis.

NCT ID: NCT01809782 Terminated - Clinical trials for Delirium and Post-operative Cognitive Dysfunction (POCD)

Cognitive Outcome After Two-stage Liver-Operation

2-StaLi
Start date: March 11, 2013
Phase: N/A
Study type: Observational

Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.