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1 Supplementary Online Content van den Boogaard M, Slooter AJC, Brüggemann RJM. Effect of haloperidol on survival among critically ill adults with a high risk of delirium: the REDUCE randomized clinical trial. JAMA. doi: /jama emethods 1. Definition of study objectives emethods 2. The use of nonpharmacologic delirium preventive interventions in the participating centers efigure 1. Time Sequential Analysis etable 1. Primary and secondary outcomes [per protocol analysis] efigure 2a. Forest plot with interaction for 28 days efigure 2b. Forest plot with interaction for 90 days efigure 2c. Forest plot with interaction for delirium incidence This supplementary material has been provided by the authors to give readers additional information about their work American Medical Association. All rights reserved.
2 - G. Hannink, Ph.D., scientific researcher, Radboud university medical center, the Netherlands emethods 1. Definition of study objectives Objective Survival days in 28-days and 90- days Delirium diagnosis Delirium-and-coma-free days in 28-days Duration of mechanical ventilation Incidence of re-intubation Incidence of ICU readmission Side effects Serious Adverse Event Definition Number of days that patients survived in 28-day and 90-day after inclusion. All patients will be classified as either alive at study day 28, and 90 or, if dead, dead at study day 28 and 90 on an intention to treat basis Patients were diagnosed as delirious when they have at least one positive CAM-ICU or ICDSC screening during their complete ICU stay. Patients who were not delirious during their ICU-stay were considered as non-delirious patients. Number of days that the patient was alive and not delirious and not in coma in 28 days starting from the day of inclusion. A delirium-andcoma-free day is defined as a negative CAM-ICU or ICDSC screening with a Richmond Agitation Sedation Score (RASS) greater than (more alert than) -3/-4/-5 during a day. In case a delirious patient was discharged to the ward, a delirium-free day was defined as a delirium observation scale (DOS) score 24 of less than 3 during a complete day. Time in days that the patient was on the mechanical ventilator. If the patient was ventilated mechanically several times, then the ventilator times were added. Both invasive and non-invasive ventilation were registered. Patients who needed re-intubation within 28 days from inclusion, following a previous extubation, irrespectively the reason for reintubation, were counted as incident case for re-intubation Patients who were readmitted to the ICU within 28 days from inclusion, irrespectively the reason for readmission, were counted as incident cases for ICU readmission Drowsiness, agitation, QTc-time prolongation (using 12-leads ECG or monitor strip with Bazett s formula) and development of extra pyramidal symptoms: dystonia - tremor- myoclonus tics rigidity akathisia 26, determined daily by physical examination by the intensivist Any untoward medical occurrence or effect at any dose that resulted in one of the following outcomes and were not classified as a clinical outcome of delirium or the underlying disease using the description above: - death that was not related to the underlying disease or sequel of the underlying disease, or death that was considered by the investigator to be possibly related to study drug - prolonged inpatient hospitalization or rehospitalisation - a life-threatening experience (immediate risk of dying) - persistent or significant disability/ incapacity - congenital anomaly/birth defect - considered significant by the investigator for any other reason 4
3 Suspected Unexpected Serious Adverse Reactions Unexpected adverse reactions were adverse reactions, of which the nature, or severity, is not consistent with the applicable product information. Adverse reactions were all untoward and unintended responses to an investigational product related to any dose administered 5
4 emethods 2. The use of non-pharmacologic delirium preventive interventions in the participating centers. Amphia hospital Canisius Wilhelmina Hospital Diakonessenhuis Utrecht Gelre hospital Haga hospital ISALA Jeroen Bosch Hospital Haaglanden Medical Center Antonishove Haaglanden Medical Center Bronovo Haaglanden Medical Center Westeinde Medical Centre Leeuwarden MMC Veldhoven Medical Spectrum Twente Onze Lieve Vrouwe Gasthuis Radboud umc Scheper hospital St Jansdal Harderwijk UMC Groningen UMC Utrecht VieCuri Medical Center Zuyderland Medical Center Overall applied (%) Early mobilization Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y 100% Improving patient circadian Y Y N Y Y N N Y Y Y N N Y Y Y Y Y Y Y Y N 71% rhythm (including sleep improvement protocol) Noise reduction strategy N Y Y Y Y N N Y Y Y N N N Y Y Y N Y Y Y N 67% Sedation protocol with less Y Y Y Y Y N N Y Y Y Y Y Y Y Y Y Y Y Y Y Y 90% sedation (RASS 0/-1) Sedation-awakening trial Y Y Y Y* Y N Y Y Y Y Y Y N N Y Y Y Y n Y Y 95% protocol Reducing use of Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y N N Y Y Y Y 90% benzodiazepines Use of hearing and visual aids Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y Y 100% Mean overall score 88% Miscellaneous:.. ** Sedation targeted station strategy 6
5 etable 1. Primary and secondary outcomes [per protocol analysis] Survival in 28-days, n (%) Survival in 90-days, n (%) Delirium incidence, n (%) Number of delirium-coma-free days in 28-days, median [IQR] Number of delirium-free days in 28-days, median [IQR] Number of coma-free days in 28-days, median [IQR] Number of days to occurrence delirium, median [IQR] Duration of mechanical ventilation in days, median [IQR] Length of stay ICU, median [IQR] Length of stay hospital, median [IQR] Incidence of ICU re-admission, n (%) Incidence of physical restraints, n (%) Incidence of unplanned removal of tubes, catheters, n (%) Incidence of re-intubation, n (%) 2 mg haloperidol (N=682) 568 (83.3) 540 (79.2) 233 (34.2) 26 (17-28) 28 (22-28) 27 (22-28) 3 (2-6) 2 (0-6) 4 (2-9) 15 (9-27) 62 (9.1) 173 (26.2) 77 (11.3) 65 (9.5) placebo (N=668) 555 (83.1) 527 (78.9) 218 (32.6) 26 (19-28) 28 (23-28) 27 (23-28) 3 (2-6) 2 (0-5) 4 (2-8) 14 (9-25) 67 (10.1) 158 (24.5) 69 (10.3) 59 (8.9) Difference (95%CI) 2 mg haloperidol - placebo 0.2 ( ) 0.3 ( ) 1.5 ( ) 1.0 ( ) 1.7 ( ) 1.0 ( ) 0.7 ( ) 1 mg haloperidol (N=331) 270 (81.6) 259 (78.2) 129 (39.0) 26 (17-28) 28 (21-28) 27 (21-28) 3 (2-6) 2 (0-7) 4 (2-9) 16 (9-30) 34 (10.3) 93 (28.8) 40 (12.1) 27 (8.2) Safety issues Maximum QTc-time in msec., median [IQR] - number of QTc-time prolongations, n (%) Incidence of extra-pyramidal symptoms - dystonia - tremor - myoclonus - tics - rigidity - akathasia 465 ( ) 29 (4.3) 1 (0.1) 6 (0.9) 4 (0.6) 4 (0.6) 3 (0.4) 4 (0.6) 462 ( ) 35 (5.2) 3 (0.4) 6 (0.9) 5 (0.7) 6 (0.9) 5 (0.7) 3 (0.4) 1.0 ( )** -1.0 ( ) 0.2 ( ) -0.1 ( ) -0.1 ( ) -0.3 ( ) -0.3 ( ) -0.1 ( ) 462 ( ) 28 (8.5) 3 (0.9) 6 (1.8) 4 (1.2) 4 (1.2) 3 (0.9) 6 (1.8) Reported Serious Adverse Events, n (%) 0 (0) 1 (0.1) -0.1 ( ) 1 (0.3) ** Differences between medians are described as absolute difference in ranking following order 7
6 Hazard Ratio 6 5 1mg haloperidol 2mg haloperidol 4 3 Monitoring boundary for benefit 2 Area of benefit 1 Futility area 0 Monitoring boundary for harm Area of harm Number of events
7 Subgroup Haza rd ratio 28 d ays su rvival HR 95%CI P-value for interaction Di agnose g roup Surgical Medical Trauma [0.62; 1.45] [0.71; 1.34] [0.23; 20.97] 0.78 A PACHE II APACHE II <20 APACHE II APACHE II > [0.54; 1.32] [0.57; 1.49] [0.73; 1.59] 0.71 PRE DELIRIC score PRE DELIRIC <20 PRE DELIRIC PRE DELIRIC > [0.30; 1.31] [0.72; 1.97] [0.66; 1.25] 0.35 Duration of pr eventive treatment 2 d ays 2 d ays > 2 d ays [0.57; 1.16] [0.81; 1.67] 0.17 Duration of pr eventive treatment 3 d ays 3 d ays > 3 d ays [0.59; 1.14] [0.83; 1.83] 0.12 Duration of pr eventive treatment 5 d ays 5 d ays > 5 d ays [0.67; 1.20] [0.72; 1.96] 0.34 Delirium Non deli rium patients Deli rium patients [0.75; 1.39] [0.57; 1.34] Halope ridol 2mg better Placebo better
8 Subgroup Haza rd ratio 90 d ays su rvival HR 95%CI P-value for interaction Di agnose g roup Surgical Medical Trauma [0.69; 1.45] [0.72; 1.28] [0.23; 20.97] 0.78 A PACHE II APACHE II <20 APACHE II APACHE II > [0.59; 1.29] [0.60; 1.43] [0.76; 1.54] 0.70 PRE DELIRIC score PRE DELIRIC <20 PRE DELIRIC PRE DELIRIC > [0.31; 1.15] [0.71; 1.66] [0.72; 1.29] 0.32 Duration of pr eventive treatment 2 d ays 2 d ays > 2 d ays [0.63; 1.17] [0.82; 1.58] 0.21 Duration of pr eventive treatment 3 d ays 3 d ays > 3 d ays [0.62; 1.11] [0.88; 1.80] 0.08 Duration of pr eventive treatment 5 d ays 5 d ays > 5 d ays [0.72; 1.22] [0.70; 1.72] 0.56 Delirium Non deli rium patients Deli rium patients [0.75; 1.32] [0.64; 1.37] Halope ridol 2mg better Placebo better
9 Stu dy O dds ratio Delirium incidence OR 95%CI P-value for interaction Di agnose g roup Surgical Medical Trauma [0.87; 1.62] [0.64; 1.24] [0.19; 2.11] 0.35 A PACHE II APACHE II <20 APACHE II APACHE II > [0.80; 1.47] [0.71; 1.76] [0.49; 1.22] 0.43 PRE DELIRIC score PRE DELIRIC <20 PRE DELIRIC PRE DELIRIC > [0.63; 1.57] [0.77; 1.66] [0.60; 1.22] 0.58 Duration of pr eventive treatment 2 d ays 2 d ays > 2 d ays [0.66; 1.21] [0.85; 1.62] 0.23 Duration of pr eventive treatment 3 d ays 3 d ays > 3 d ays [0.78; 1.36] [0.68; 1.42] 0.84 Duration of pr eventive treatment 5 d ays 5 d ays > 5 d ays [0.79; 1.30] [0.61; 1.61] Halope ridol 2mg better Placebo better
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