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NCT Number: NCT07428681

Lorazepam for Delirium Prevention in Critically Ill Patients With High Anttila-Index

Delirium is a neuropsychiatric syndrome characterized by cognitive and attentional deficits, circadian rhythm, emotional and psychomotor dysregulation.

It is frequently encountered in patients admitted to an Intensive Care Unit (ICU) with a prevalence of 20-80% and associated with higher morbidity and mortality, prolonged hospitalization and cognitive impairment after hospitalization.

Alcoholism is an important risk factor that favors the development of delirium and a common comorbidity in patients admitted to the ICU.

Patients with alcohol use disorders can develop a withdrawal syndrome after cessation of alcohol consumption. The most severe form of alcohol withdrawal is the alcohol withdrawal delirium, which is characterized by a profound state of confusion. Early recognition and treatment significantly diminish severe complications of alcohol withdrawal delirium, including mortality.

The common pharmacological prevention and therapy of alcohol withdrawal syndrome is the administration of benzodiazepines, which have the potential to prevent or mitigate alcohol withdrawal delirium.

In the ICU setting the diagnosis of alcoholism based on self-report can be unreliable and complicated by acute illness.

The Anttila-Index is a parameter calculated from the carbohydrate-deficient transferrin and the gamma-glutamyltransferase. It has a high sensitivity and specificity for excessive alcohol consumption. Therefore, the Anttila-Index of patients admitted to the ICU could help identify patients at risk for developing delirium due to alcoholism or due to alcoholism in combination with other risk factors.

Schreiber et al. recently (October 2023) found significantly higher Anttila-Index in patients with delirium on a medical ICU. The investigators postulate that this also applies to the patients admitted to the mixed (medical and surgical) ICU at the University Hospital Basel (USB), since surgery is an additional crucial risk factor for delirium development.

Hypothesis: ICU delirium can be reduced by careful preventive administration of lorazepam in patients admitted to the ICU with an Anttila-Index at or above the cutoff value of four.

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Key information

Conditions

Delirium Confusional State Confusion Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Emergency/unplanned admission to the ICU
Age ≥ 18 years
ICU stay ≤ 24 hours until first study intervention
Hospital admission ≤ 24 hours before ICU admission
Anttila-Index ≥ 4

Exclusion criteria

Pre-existing delirium
Admission diagnosis that requires the administration of benzodiazepines (e.g. epileptic seizure)
Pre-existing therapy with benzodiazepines
Women: Pregnancy or breastfeeding
Sequelae of acute intoxication (drugs or alcohol) at time of inclusion
Hypersensitivity, allergy, or other absolute contraindication to lorazepam
Participation in another study with investigational drug within the 30 days preceding and during the present study

Treatment and study plan

Lorazepam 1 mg

Drug

0.5-1mg intravenously administered every 6 hours for 3 days

Placebo

Drug

same amount (ml) of an identical viscous, oily solution without any pharmacological activity intravenously administered every 6 hours for 3 days

Primary outcomes

Incidence of ICU delirium (yes/no)

Time frame: until day 3 after first study intervention

Study contacts

Contact information is provided by the study sponsor or research team.

PD Dr. med. A. Hollinger, MD

CONTACT

Prof. Dr. med. M. Siegemund, MD

CONTACT

[email protected]

+41(0)613286414

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Preventive Administration of Lorazepam in Critically Ill Patients With High Anttila-Index to Reduce the Incidence of Intensive Care Delirium: a Single-centre, Randomized, Controlled Clinical Trial - the Basel LOC2DEL-Trial

Acronym: LOC2DEL

Important dates

Study start: 2027
Primary completion: 2028
Study completion: 2029
First posted: Feb 24, 2026
Registry last updated: Feb 27, 2026

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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