Thiamine Administration and Prevalence of Delirium in the Intensive Care Unit: A Before-after Study

NCT04214106 | Completed FDA Drug

• 1 other identifier: 0277-19-MMC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is a very common condition among ICU-admitted patients, and its prevalence is estimated between 30-40%. Delirium is associated with increased morbidity and mortality and future cognitive decline, along with increased ventilation-dependency and other complications. There are multiple risk factors for delirium, including deficiencies of micronutrients. Thiamine deficiency is associated with specific neurological syndromes, including Wernicke and Korsakoff syndromes and Delirium Tremens. Several studies demonstrated significant thiamine deficiency among ICU-admitted patients (prevalence of 30-70%) without known risk factors, such as alcohol dependency. Thiamine deficiency may cause delirium in those patients. Intravenous thiamine had been safely used for decades, for several indications. Lately, thiamine has been advocated for therapy in patients with septic shock, and its use in intensive care units has increased worldwide. Since 2016, thiamine has been routinely administered in our intensive care unit. Considering the theoretical association between thiamine deficiency and ICU-related delirium, the investigators aim to investigate whether the routine use of thiamine has been associated with decreased prevalence of delirium among ICU patients when compared to the pre-routine thiamine administration era.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Delirium score

  RASS score (Richmond agitation-sedation scale, from minus 5 to plus 4, desirable score 0)

  Average RASS score during ICU-hospitalization, through study completion, an average of 1 year

Study Arms (2)

Thiamine group

group 1: ICU patients who did not receive IV thiamine

Non-thiamine group

group 2: ICU patients who received IV thiamine,100-500 mg/day for at least one day

Drug: intravenous Thiamine

Interventions

intravenous Thiamine DRUG

patients who received Thiamine,100-500 mg/day for at least one day

Non-thiamine group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients, aged 18-99, admitted to the intensive care unit in our medical facility between the years 2014-2018 (two years before and after intervention).

You may qualify if:

• All patients, aged 18-99, admitted to the intensive care unit in our medical facility between the years 2014-2018 (two years before and after intervention).

You may not qualify if:

• Patients who were treated with thiamine prior to ICU admission, and patients who did not receive thiamine in the ICU.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir medical center Kfar Saba

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: January 2, 2020
• Study Start: February 19, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

IL (1)