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NCT Number: NCT04214106

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir medical center Kfar Saba

Kfar Saba, Israel

About this study

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.

Primary endpoint: Average delirium score during ICU-hospitalization before and after the routine intravenous thiamine administration.

Secondary endpoints: ICU and hospital admission times, duration of ventilation, need for tracheostomy, need for anti-delirium therapy and 28-day mortality.

Study design: Retrospective before-after interventional study. Inclusion criteria: 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).

Exclusion criteria

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

Data collection: Data will be collected from the patients' electronic management file (iMD soft, Ofek and Chameleon software). Data collection will be anonymous.

Data: Age, gender, ICU and hospital admission times, duration of ventilation, 28-day mortality, need for tracheostomy. Need for anti-delirium therapy, cause for ICU admission, medical history, regular medication therapy, APACHE-2 score, SOFA score, lactate levels, need for inotropic or vasopressor support, need for physical restraints, need for renal replacement therapy, use of medication which may increase risk for delirium, RASS score.

Cohort size: 1000 patients overall, 500 in each study group (before and after intervention).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

intravenous Thiamine

Drug

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

Primary outcomes

  1. Delirium score

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

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

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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