Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital

The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan

Research output: Contribution to journalJournal articleResearchpeer-review


  1. A marking of the cricothyroid membrane with extended neck returns to correct position after neck manipulation and repositioning

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Association between transfusion of blood products and acute kidney injury following cardiac surgery

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Ketamine for rapid sequence intubation in adult trauma patients: A retrospective observational study

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Lactate versus acetate buffered intravenous crystalloid solutions: a scoping review

    Research output: Contribution to journalReviewResearchpeer-review

  2. Evaluating Non-Statistically Significant Results From Trials in Practice-Reply

    Research output: Contribution to journalComment/debateResearchpeer-review

View graph of relations

BACKGROUND: The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial.

METHODS: The AID-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomized, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomization. Secondary outcome measures are days alive without delirium or coma, serious adverse reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomization. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables.

CONCLUSION: The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Issue number9
Pages (from-to)1357-1364
Number of pages8
Publication statusPublished - 1 Oct 2020

Bibliographical note

© 2020 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

ID: 60260918