Delirium Confusional StatePhase 4LOC2DELNCT07428681
Lorazepam for Delirium Prevention in Critically Ill Patients With High Anttila-Index
A Phase 4 study testing Lorazepam 1 mg in people with Delirium Confusional State, run by University Hospital, Basel, Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium Confusional State
- What is being tested?
- Lorazepam 1 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Feb 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
PD Dr. med. A. Hollinger, MD contact
About this study
Official 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
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.
Read more
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.
- Conditions
- Delirium Confusional State
- Being tested
- Lorazepam 1 mg, Placebo
- Medical subject headings
- Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorazepam 1 mgDrug
0.5-1mg intravenously administered every 6 hours for 3 days
PlaceboDrug
same amount (ml) of an identical viscous, oily solution without any pharmacological activity intravenously administered every 6 hours for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam | Experimental | Not described Receives: Drug: Lorazepam 1 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ICU delirium (yes/no)
Measured: until day 3 after first study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startMar 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium Confusional StateStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428681
- Sponsor's protocol ID
- LOC2DEL
- Acronym
- LOC2DEL
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07428681
- Acronym / sponsor ID
- LOC2DEL / LOC2DEL
- Conditions
- Delirium Confusional State
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorazepam | Experimental | Drug: Lorazepam 1 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorazepam 1 mg0.5-1mg intravenously administered every 6 hours for 3 days | Drug | Lorazepam |
| Placebosame amount (ml) of an identical viscous, oily solution without any pharmacological activity intravenously administered every 6 hours for 3 days | Drug | Placebo |
Primary outcome
Incidence of ICU delirium (yes/no)
Time frame: until day 3 after first study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PD Dr. med. A. Hollinger, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lorazepam 1 mg in people with Delirium Confusional State, run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. med. M. Siegemund, MD (+41(0)613286414, martin.siegemund@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ICU delirium (yes/no) (time frame: until day 3 after first study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.