Treatment for Delirium

2
Effectiveness
3
Safety
Vanderbilt University Medical Center, Nashville, TN
Delirium+6 More
Eligibility
< 18
All Sexes
Eligible conditions
Delirium

Study Summary

This study is evaluating whether a sedative medication can reduce delirium and improve outcomes in pediatric patients.

See full description

Eligible Conditions

  • Delirium
  • Stress Disorders, Traumatic
  • Critical Illness
  • Moral Injury
  • Sedation Complication
  • Executive Dysfunction
  • Post Traumatic Stress Disorder (PTSD)
  • Stress Disorders, Post-Traumatic

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 10 secondary outcomes in patients with Delirium. Measurement will happen over the course of 14 days.

14 days
Daily prevalence of delirium
Duration of mechanical ventilation (MV)
Organ Dysfunction
30 days
ICU and hospital lengths of stay
Incidence of Iatrogenic Withdrawal Syndrome
Month 6
Incidence of long-term cognitive impairment.
90 days
Mortality
Month 6
Functional status
Incidence of post-traumatic stress symptoms in patients and parents/caregivers
Day 1
Markers of Inflammation, endothelial and blood brain barrier injury
Day 30
Sedation Level

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Midazolam

This trial requires 372 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Midazolam
Drug
Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 0.5 mg/mL midazolam. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice. Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the midazolam group, dose will range from 0.025-0.25 mg/kg/hr.
Dexmedetomidine
Drug
Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of 4 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice. Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.2-2.0 mcg/kg/hr.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months post icu discharge
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months post icu discharge for reporting.

Who is running the study

Principal Investigator
H. A. B. S.
Prof. Heidi A. Beverley Smith, Associate Professor
Vanderbilt University Medical Center

Closest Location

Vanderbilt University Medical Center - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients will be eligible for enrollment if they are 1) aged ≥ 6 months and < 11 years, 2) admitted to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt (MCJCHV), and 3) on mechanical ventilation (MV) requiring sedation. Pre-pubescent children (<11 years) are typically different from older children who often behave physiologically more similar to adults. Pre-pubescent children are more likely to be admitted to the PICU and are undergoing a steeper curve of neurocognitive maturation. Therefore, these patients may be at greatest risk for worse brain dysfunction.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is delirium?

Add answer

Delirium may occur in any stage of life and may manifest in many ways. An episodic or acute onset of delirium is often described and thought to be a normal developmental response that may occur as a result of stress, illness or treatment, and the impact of its presence remains to be realised. Early awareness of delirium is vital to maintain the patients status, and its prevention and treatment are important. The key is to identify the predisposing factors that are responsible for the development or aggravation of delirium - the risk factors, especially the 'dysregulation of arousal system in delirium.

Unverified Answer

What are the signs of delirium?

Add answer

The authors of this study did not find any unequivocal signs of delirium in patients being discharged from hospital to the post-acute wards of their hospitals. However, when considering those patients discharged to the post-acute wards, patients should be aware of a variety of signs and symptoms of delirium. These include: changes in arousal, attention span, and memory. There is a need for further work, on the definition of delirium and its clinical usefulness, as well as other clinical guidelines for the assessment and referral of delirium. Results from a recent clinical trial highlights the importance of this area of study.

Unverified Answer

What causes delirium?

Add answer

Dementia in the elderly is multifactorial and associated with a variety of psychiatric and metabolic disturbances. The high prevalence of depression and psychosocial stress-related symptoms observed in patients with delirium may explain these connections. These links between delirium and dementia may help us understand the etiology of dementia.

Unverified Answer

How many people get delirium a year in the United States?

Add answer

Although the prevalence of delirium was similar for older adults without dementia and those with dementia, the likelihood of experiencing delirium was significantly greater for those with dementia. Thus, delirium may be more a problem for older adults with dementia than for those without dementia. The strongest independent predictors of having delirium were the same as for having dementia. Recent findings highlight the need for further research into the risk factors for delirium among older adults.

Unverified Answer

Can delirium be cured?

Add answer

Delirium is not a cure for dementia and in most respects does not need to be treated, but good quality palliative care and early detection may result in better quality of life in older people.

Unverified Answer

What are common treatments for delirium?

Add answer

There is significant over-prescribing of sedation use in patients with delirium in nursing homes and general hospitals. Appropriate use of sedatives may lessen delirium symptomatology, shorten length of stay, and enhance patient safety.

Unverified Answer

What is treatment?

Add answer

Delirium is highly prevalent in ICU patients and is a substantial barrier to the recovery of these patients. The management of delirium is the cornerstone of care in patients recovering from critical illness. Pharmacological agents are used as first line treatment based on high-quality evidence, whilst psychological therapies are used more systematically to manage the patient more socially with the family. Physical therapists can play an important role with respect to pain, particularly the care of skin burns, in addition to physiotherapy or occupational therapy.

Unverified Answer

What is the latest research for delirium?

Add answer

In a recent study, findings focused on delirium research but it will add to the knowledge base for this topic. However, we recommend that future research should examine patients carefully because the prevalence and consequences of postoperative delirium would be a serious problem in any hospital, regardless of the type of surgery.

Unverified Answer

Has treatment proven to be more effective than a placebo?

Add answer

Based on the review of the literature, there is neither evidence nor evidence that the treatment of insomnia and antipsychotic medications in psychosis result in significant effectiveness for any of the reviewed variables. The reviews also reported insufficient levels of evidence that treatment is more effective than a placebo for the reviewed variables except for improvement on the psychosocial variables. The treatment of insomnia may have some effect on psychoses but there was inadequate evidence. These were considered to be not conclusive evidence that treatment is more effective than a placebo.

Unverified Answer

How serious can delirium be?

Add answer

Findings from a recent study of older persons (mean age 80 years), delirium is associated with a 2-month higher mortality than in the control group. More than a third of persons with delirium survived 1 year. Mortality risk appeared higher among those with longer delirium length (>3 days) vs <3 days, and for males vs females.

Unverified Answer

What is the average age someone gets delirium?

Add answer

On average, people with delirium who were hospitalized had an age of 93.1 at presentation and a lifetime risk of dementia of 0.56. The prevalence of delirium was 7.1% in the inpatient group and 11.4% in the community. These rates of delirium in older patients hospitalized because of an acute disease are higher than those previously reported.

Unverified Answer

Does treatment improve quality of life for those with delirium?

Add answer

Delirium, regardless of severity, significantly reduces physical and mental HRQoL. Delirium was associated with a reduction in physical HRQoL while no significant associations were found with mental HRQoL, indicating a difference in mechanism.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Delirium by sharing your contact details with the study coordinator.