UnknownPhase 4

Agents Intervening Against Delirium in Intensive Care Unit

Denmark, Finland, Italy1,000 participantsStarted 2018-06-13

Plain-language summary

Delirium is a frequent condition in the Intensive Care Unit (ICU) with no existing evidence-based treatment. The aim of the AID-ICU study is to assess the benefits and harms of haloperidol treatment for the management of ICU acquired delirium.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Acute admission to the ICU AND * Age ≥ 18 years AND * Diagnosed delirium with validated screening Tool as either CAM-ICU or ICDSC Exclusion Criteria: * Contraindications to haloperidol * Habitual treatment with any antipsychotic medication or treatment with antipsychotics in the ICU prior to inclusion * Permanently incompetent (e.g. dementia, mental retardation) * Delirium assessment non-applicable (coma or language barriers) * Withdrawal from active therapy * Fertile women (women \< 50) with positive urine human chorionic gonadotropin (hCG) or plasma hCG. * Consent according to national regulations not obtainable * Patients under coercive measures by regulatory authorities * Patients with alcohol-induced delirium (Delirium Tremens)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Days alive out of the hospital within 90 days post-randomization

Timeframe: 90 days

90-day mortality

Timeframe: 90 days

Hospital Length of Stay

Timeframe: 90 days

Trial details

NCT IDNCT03392376

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-09

View on ClinicalTrials.gov More Delirium trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.