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1.
Intensive Care Med ; 50(1): 103-113, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38170227

ABSTRACT

PURPOSE: We assessed long-term outcomes in acutely admitted adult patients with delirium treated in intensive care unit (ICU) with haloperidol versus placebo. METHODS: We conducted pre-planned analyses of 1-year outcomes in the Agents Intervening against Delirium in the ICU (AID-ICU) trial, including mortality and health-related quality of life (HRQoL) assessed by Euroqol (EQ) 5-dimension 5-level questionnaire (EQ-5D-5L) index values and EQ visual analogue scale (EQ VAS) (deceased patients were assigned the numeric value zero). Outcomes were analysed using logistic and linear regressions with bootstrapping and G-computation, all with adjustment for the stratification variables (site and delirium motor subtype) and multiple imputations for missing HRQoL values. RESULTS: At 1-year follow-up, we obtained vital status for 96.2% and HRQoL data for 83.3% of the 1000 randomised patients. One-year mortality was 224/501 (44.7%) in the haloperidol group versus 251/486 (51.6%) in the placebo group, with an adjusted absolute risk difference of - 6.4%-points (95% confidence interval [CI] - 12.8%-points to - 0.2%-points; P = 0.045). These results were largely consistent across the secondary analyses. For HRQoL, the adjusted mean differences were 0.04 (95% CI - 0.03 to 0.11; P = 0.091) for EQ-5D-5L-5L index values, and 3.3 (95% CI - 9.3 to 17.5; P = 0.142) for EQ VAS. CONCLUSIONS: In acutely admitted adult ICU patients with delirium, haloperidol treatment reduced mortality at 1-year follow-up, but did not statistically significantly improve HRQoL.


Subject(s)
Delirium , Haloperidol , Adult , Humans , Delirium/drug therapy , Haloperidol/therapeutic use , Hospitalization , Intensive Care Units , Quality of Life
3.
Intensive Care Med ; 48(2): 201-212, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34904191

ABSTRACT

PURPOSE: A reliable tool for outcome prognostication in severe traumatic brain injury (TBI) would improve intensive care unit (ICU) decision-making process by providing objective information to caregivers and family. This study aimed at designing a new classification score based on magnetic resonance (MR) diffusion metrics measured in the deep white matter between day 7 and day 35 after TBI to predict 1-year clinical outcome. METHODS: Two multicenter cohorts (29 centers) were used. MRI-COMA cohort (NCT00577954) was split into MRI-COMA-Train (50 patients enrolled between 2006 and mid-2014) and MRI-COMA-Test (140 patients followed up in clinical routine from 2014) sub-cohorts. These latter patients were pooled with 56 ICU patients (enrolled from 2014 to 2020) from CENTER-TBI cohort (NCT02210221). Patients were dichotomised depending on their 1-year Glasgow outcome scale extended (GOSE) score: GOSE 1-3, unfavorable outcome (UFO); GOSE 4-8, favorable outcome (FO). A support vector classifier incorporating fractional anisotropy and mean diffusivity measured in deep white matter, and age at the time of injury was developed to predict whether the patients would be either UFO or FO. RESULTS: The model achieved an area under the ROC curve of 0.93 on MRI-COMA-Train training dataset, and 49% sensitivity for 96.8% specificity in predicting UFO and 58.5% sensitivity for 97.1% specificity in predicting FO on the pooled MRI-COMA-Test and CENTER-TBI validation datasets. CONCLUSION: The model successfully identified, with a specificity compatible with a personalized decision-making process in ICU, one in two patients who had an unfavorable outcome at 1 year after the injury, and two-thirds of the patients who experienced a favorable outcome.


Subject(s)
Brain Injuries, Traumatic , White Matter , Benchmarking , Brain Injuries, Traumatic/diagnostic imaging , Humans , Intensive Care Units , Magnetic Resonance Imaging , Prognosis , White Matter/diagnostic imaging
4.
Intensive Care Med ; 33(9): 1580-6, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17541545

ABSTRACT

OBJECTIVE: To collect information on clinical practice and current management strategies in 22 Italian neurosurgical hospitals for patients with aneurysmal subarachnoid hemorrhage. DESIGN AND SETTING: Observational 6-month study for prospective data collection. PATIENTS: 350 cases of aneurysmal subarachnoid hemorrhage. MEASUREMENTS AND RESULTS: Each center enrolled from 4-36 patients. Neurological deterioration (24%) was more frequent in patients with higher Fisher classification, and with pretreatment rebleeding and it was associated with an unfavorable outcome (46%, 36/78, vs. 33%, 83/251). Aneurysms were mainly secured by clipping (55%, 191/350). An endovascular approach was utilized in 35% (121/350). The more frequent medical complications were fever, recorded in one-half of cases, pneumonia (18%), sodium disturbances (hyponatremia 22%, hypernatremia 17%), cardiopulmonary events as neurogenic pulmonary edema (4%) and myocardial ischemia (5%). Intracranial hypertension was experienced in one-third of the patients, followed by hydrocephalus (29%) and vasospasm (30%). Cerebral ischemia was found in an about one-quarter of the cohort. To identify the independent predictors of outcome we developed a model in which the dichotomized Glasgow Outcome Scale was tested as function of extracranial and intracranial complications. Only high intracranial pressure and deterioration in neurological status were independent factors related to unfavorable outcome. CONCLUSIONS: Our data confirm that in every step of care there is extreme heterogeneity among centers. These patients are complex, with comorbidities, immediate risk of rebleeding, and delayed risk of intracranial and medical complications. Following SAH early treatment and careful intensive care management requires the careful coordination of the various clinical specialties.


Subject(s)
Embolization, Therapeutic/statistics & numerical data , Subarachnoid Hemorrhage/therapy , Surgical Instruments/statistics & numerical data , Age Factors , Cerebral Angiography , Embolization, Therapeutic/adverse effects , Female , Humans , Intracranial Hypertension/complications , Intracranial Hypertension/epidemiology , Italy/epidemiology , Logistic Models , Male , Middle Aged , Prospective Studies , Risk Factors , Rupture/diagnosis , Rupture/therapy , Severity of Illness Index , Subarachnoid Hemorrhage/diagnosis , Subarachnoid Hemorrhage/epidemiology , Surgical Instruments/adverse effects
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