Pharmacological Management of Delirium (PMD)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
In 2005, approximately 2.7 million Americans aged 65 and older spent at least one day in the intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that while hospitalized, up to 80% of these older ICU patients had delirium, an acute brain failure that is an independent predictor of morbidity and mortality which often goes unrecognized. Older adults with delirium are more prone to falls, injuries, pressure ulcers and restraints, complications which may also contribute to prolonged ICU and hospital length of stay, higher mortality rates, poorer functional status, limited rehabilitation, increased institutionalization, and higher health care costs. The literature supports treatment with a combination of a reduction in the use of benzodiazepines and anticholinergics and the use of low-dose neuroleptics such as haloperidol. However, there have been no randomized controlled trials evaluating the efficacy of this approach on reducing delirium severity, duration, and complications.
Building upon the e-CHAMP study, ("Enhancing Care for Hospitalized Older Adults With Memory Problems;" see NCT00182832), a recently completed quality improvement project tested the effectiveness of cognitive screening coupled with computerized decision support in reducing delirium and other hospital-related complications among 424 older adults hospitalized on the medical wards, which found that many of the older adults entering the study had already experienced delirium in the ICU prior to their transfer to the wards. This study will test a pharmacologic intervention that allows a more targeted approach to the care of older adults with delirium while still recognizing the clinicians' role in controlling symptoms and providing intensive care.
The hypothesis is that patients in the intervention arm as compared to usual care will have:
- reduced delirium severity, as measured by the Delirium Rating Scale (DRS-R-98), at one week following randomization or hospital discharge
- fewer hospital days with delirium or coma as determined by the Confusion Assessment Method in the ICU (CAM-ICU)
- shorter hospital lengths of stay
- lower ICU, hospital, and 30-day mortality
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
- Methodist Hospital
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Indianapolis, Indiana, Stati Uniti, 46202
- University Hospital
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Indianapolis, Indiana, Stati Uniti, 46202
- Eskenazi Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18 years of age or older
- Hospitalized on an ICU ward
- Delirium based on the RASS and the CAM-ICU assessments at any day during ICU stay
- English speaking
Exclusion Criteria:
- Admitted directly to a regular non-ICU ward
- Previously enrolled in the study
- Not eligible for delirium assessment as determined by RASS scores
- Prior history of severe mental illness
- Alcohol-related delirium
- Pregnant or nursing
- Have had an aphasic stroke
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
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Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug. Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital
Altri nomi:
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Comparatore attivo: Haloperidol Eligible Usual Care
Usual care
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May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
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Sperimentale: Haldol-Ineligible Arm
Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures. Patients are randomized and will still receive: reduced exposure to anticholinergics, reduced exposure to benzodiazepines |
Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug. Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
|
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Comparatore attivo: Haldol Ineligible Usual Care
Usual Care
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May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Days Free of Delirium and Coma
Lasso di tempo: Admission through day 8 of stay
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Admission through day 8 of stay
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Hospital Length of Stay Post Randomization
Lasso di tempo: Participants were followed for the duration of hospital stay, an average of 11 days
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Participants were followed for the duration of hospital stay, an average of 11 days
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Mortality
Lasso di tempo: ICU, in-hospital, 30-days post hospitalization
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ICU, in-hospital, 30-days post hospitalization
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Malaz Boustani, MD, Indiana University School of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- Ortiz D, Lindroth HL, Braly T, Perkins AJ, Mohanty S, Meagher AD, Khan SH, Boustani MA, Khan BA. Delirium severity does not differ between medical and surgical intensive care units after adjusting for medication use. Sci Rep. 2022 Aug 24;12(1):14447. doi: 10.1038/s41598-022-18429-9.
- Lindroth H, Khan BA, Carpenter JS, Gao S, Perkins AJ, Khan SH, Wang S, Jones RN, Boustani MA. Delirium Severity Trajectories and Outcomes in ICU Patients. Defining a Dynamic Symptom Phenotype. Ann Am Thorac Soc. 2020 Sep;17(9):1094-1103. doi: 10.1513/AnnalsATS.201910-764OC.
- Khan BA, Perkins AJ, Campbell NL, Gao S, Farber MO, Wang S, Khan SH, Zarzaur BL, Boustani MA. Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial. J Am Geriatr Soc. 2019 May;67(5):1057-1065. doi: 10.1111/jgs.15781. Epub 2019 Jan 25.
- Campbell NL, Khan BA, Farber M, Campbell T, Perkins AJ, Hui SL, Abernathy G, Buckley J, Sing R, Tricker J, Zawahiri M, Boustani MA. Improving delirium care in the intensive care unit: the design of a pragmatic study. Trials. 2011 Jun 6;12:139. doi: 10.1186/1745-6215-12-139.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattie del sistema nervoso
- Manifestazioni neurologiche
- Confusione
- Manifestazioni neurocomportamentali
- Disturbi neurocognitivi
- Delirio
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Depressori del sistema nervoso centrale
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti colinergici
- Antiemetici
- Agenti gastrointestinali
- Agenti antipsicotici
- Agenti tranquillanti
- Psicofarmaci
- Agenti dopaminergici
- Antagonisti della dopamina
- Agenti anti-discinesia
- Aloperidolo
- Aloperidolo decanoato
- Antagonisti colinergici
Altri numeri di identificazione dello studio
- IA0145
- R01AG034205 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Delirio
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Chimei Medical CenterNon ancora reclutamento
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University Hospital, Basel, SwitzerlandNon ancora reclutamentoDelirium Stato confusionale
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University of Southern CaliforniaTerminatoDelirio | Effetti collaterali del trattamento | Moralità | Delirio in età avanzata | Psico | Delirio di origine mista | Delirium Stato confusionale | Delirium, associato a sepsiStati Uniti
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University of ChileFondo Nacional de Desarrollo Científico y Tecnológico, FONDECYT (Chile).Sconosciuto
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Duke UniversityNon ancora reclutamentoDelirium Stato confusionale | Delirio iperattivo | Delirio in Terapia Intensiva | Delirio AgitatoStati Uniti
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Jubilee Mission Medical College and Research InstituteINCRE fellowship from DBT, govt of IndiaCompletatoSintomi di astinenza da alcol | Delirium Tremens (DT)
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Ain Shams UniversityNon ancora reclutamento
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University of Medicine and Pharmacy at Ho Chi Minh...SconosciutoIncidenza del delirium nei pazienti anziani ricoveratiVietnam
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University Hospital OstravaReclutamentoEmergence Delirium, anestesiaCechia
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Assiut UniversityNon ancora reclutamentoEmergence Delirium, anestesiaEgitto