AID ICU
Research type
Research Study
Full title
Agents Intervening against Delirium in the Intensive Care Unit (AID ICU) A randomised, blinded, placebo-controlled trial.
IRAS ID
270152
Contact name
Matthew Wise
Contact email
Sponsor organisation
Zealand University Hospital
Eudract number
2017-003829-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Research Summary
Title: Does the drug haloperidol improve survival of critically ill patients with delirium?\n\nDelirium is a type of temporary brain dysfunction which often occurs during a severe illness. Although the exact mechanisms are poorly understood, patients may experience disorganised thinking, hallucinations, changes in mood and an altered level of consciousness with or without agitation. Delirium is common, affecting between 30-80% of patients in intensive care. Its presence is associated with longer hospital stays, higher costs of care, long-term disability and even higher rates of death. Delirium is therefore a common, important and scary problem for both patients and the public.\n\nMany drugs are used to treat delirium including antipsychotics, sedatives and painkillers. It is unclear if these drugs are effective or safe. A recent study found that in 99 ICUs (intensive care units), the drug haloperidol was the most frequently used. Some international guidelines recommend haloperidol although no high-quality clinical trials have established efficacy or safety. The Society of Critical Care Medicine have emphasised the need for a clinical trial. Before testing the other drugs sometimes used (e.g. antipsychotics) we first need to establish firm evidence that haloperidol is superior to placebo in treating delirium in ICU patients.\n\nThis international, multi-centre trial will randomise intensive care patients with delirium to placebo or haloperidol. This will include 1000 non-pregnant, adult patients with no contraindications to haloperidol and no pre-existing antipsychotic use. They will be given a small dose of haloperidol or saline placebo into their veins three times per day. Further doses can be given if needed. Their delirium status will be tested twice a daily with a validated screening tool. They will be followed up for 90 days in hospital and one year with a questionnaire by phone.\n\nCardiff & Vale University Health Board will act as UK coordinating centre, with study Sponsors based in Denmark\n
Summary of Results
Agents Intervening against Delirium in the Intensive Care Unit. (AID-ICU) A randomised, blinded, placebo-controlled trial.
Delirium is common in patients who are critically unwell and has symptoms such as agitation, disorganised thinking and fluctuating conscious levels. Haloperidol is a common drug that is used to treat delirium, however there is no solid evidence on the harmful or beneficial effects of it being used in this scenario.
AID ICU was designed to assess the benefits and harms of the drug haloperidol in adults who had been admitted to Intensive Care Units and developed delirium. The main question of the research was 'does haloperidol, compared with placebo, increase the number of days alive and out of hospital at 90 days in patients with delirium in Intensive Care'.
The trial was led by a team of researchers in Denmark who are part of the Collaboration for Research in Intensive group (CRIC) To read more about them and their work follow this link - About CRIC - CRIC - Collaboration for Research in Intensive Care) The study was funded by Innovation Fund Denmark and The Regional Medicines Foundation and recruited in Denmark, Finland, Norway, Germany, Spain, Italy, France and the UK.
In the UK the study was led by Dr Matt Morgan from Cardiff and Vale University Health Board and Cardiff was the only recruiting site in the UK.
1000 patients were recruited overall with 50% receiving haloperidol 3 times a day, plus any additional doses required and 50% receiving a placebo of saline 3 times a day, plus any additional doses required. This continued until patients no longer had delirium or were discharged from Intensive Care. Patients were assessed for delirium twice a day during this time and were assessed for any safety concerns. Patients were followed up at 90 days and 1 year to assess survival and quality of life.
The study showed that there was no difference between the two groups meaning that haloperidol did not lead to a longer time alive and out of hospital than placebo. There was no difference in the number of adverse events in either group.
Read the full paper here: Haloperidol for the Treatment of Delirium in ICU Patients | New England Journal of Medicine Read the research summary here: nejmoa2211868_research-summary.pdfREC name
Wales REC 3
REC reference
20/WA/0311
Date of REC Opinion
21 Dec 2020
REC opinion
Further Information Favourable Opinion