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

被引:10
作者
Andersen-Ranberg, Nina [1 ,2 ]
Poulsen, Lone M. [1 ,2 ]
Perner, Anders [2 ,3 ]
Wetterslev, Jorn [2 ,4 ]
Mathiesen, Ole [1 ,2 ]
Mortensen, Camilla B. [1 ,2 ]
Estrup, Stine [1 ,2 ]
Ebdrup, Bjorn H. [5 ,6 ,7 ]
Hastbacka, Johanna [8 ]
Citerio, Giuseppe [9 ]
Caballero, Jesus [10 ]
Morgan, Matthew P. G. [11 ]
Oxenboll-Collet, Marie [3 ]
Weber, Sven-Olaf [12 ]
Andreasen, Anne Sofie [13 ]
Bestle, Morten H. [7 ,14 ]
Pedersen, Helle B. S. [15 ]
Nielsen, Louise G. [16 ]
Uslu, Bulent [17 ]
Jensen, Troels B. [18 ]
Thee, Carsten [19 ]
Dey, Nilanjan [20 ]
Lange, Theis [2 ,21 ]
机构
[1] Zealand Univ Hosp, Dept Anaesthesiol & Intens Care Med, Koege, Denmark
[2] Ctr Res Intens Care CRIC, Copenhagen, Denmark
[3] Copenhagen Univ Hosp, Rigshosp, Dept Intens Care, Copenhagen, Denmark
[4] Copenhagen Univ Hosp, Rigshosp, Ctr Clin Intervent Res, Dept 7812,Copenhagen Trial Unit CTU, Copenhagen, Denmark
[5] Univ Copenhagen, Ctr Neuropsychiat Schizophrenia Res CNSR, Glostrup, Denmark
[6] Univ Copenhagen, Ctr Clin Intervent & Neuropsychiat Schizophrenia, Mental Hlth Ctr Glostrup, Glostrup, Denmark
[7] Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark
[8] Helsinki Univ Hosp, Dept Anaesthesiol, Helsinki, Finland
[9] Uni Milano Bicocca, Monza, Italy
[10] Univ Autonoma Barcelona UAB, Dept Med, IRBLLeida, Hosp Univ Arnau de Vilanova Lleida, Barcelona, Spain
[11] Univ Wales Coll Cardiff, Adult Crit Care, Cardiff, Wales
[12] Aalborg Univ Hosp, Gen Intens Care Unit, Aalborg, Denmark
[13] Herlev Hosp, Dept Anesthesiol & Intens Care, Intens Care Unit, Herlev, Denmark
[14] Nordsjaellands Hosp, Dept Anaesthesiol & Intens Care, Hillerod, Denmark
[15] Nykobing Falster Hosp, Dept Anaesthesiol & Intens Care, Nykobing, Denmark
[16] Univ Southern Denmark, Odense Univ Hosp, Dept Intens Care, Odense, Denmark
[17] Zealand Univ Hosp, Dept Anaesthesiol & Intens Care Med, Roskilde, Denmark
[18] Hosp Unit West Jutland, Dept Anaesthesiol & Intens Care Med, Herning, Denmark
[19] Hosp Sonderjylland, Dept Anaesthesiol & Intens Care Med, Aabenraa, Denmark
[20] Hosp Unit West Jutland, Dept Anaesthesiol & Intens Care Med, Holstebro, Denmark
[21] Univ Copenhagen, Dept Publ Hlth, Sect Biostat, Copenhagen, Denmark
关键词
MECHANICALLY VENTILATED PATIENTS;
D O I
10.1111/aas.13661
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
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.
引用
收藏
页码:1357 / 1364
页数:8
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