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Pharmacological Management of Delirium (PMD)

16. august 2018 oppdatert av: MALAZ BOUSTANI, Indiana University
The purpose of this study is to develop and test the feasibility of using a specific pharmacological protocol to reduce delirium burden among older adults in the Intensive Care Unit (ICU). The study will test the efficacy of a pharmacological intervention in reducing delirium severity and duration as well as length of stay and mortality compared to usual care.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Faktiske)

551

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Methodist Hospital
      • Indianapolis, Indiana, Forente stater, 46202
        • University Hospital
      • Indianapolis, Indiana, Forente stater, 46202
        • Eskenazi Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
Atferdsmessig: Reduced exposure to anticholinergics

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

Fremgangsmåte: Reduced exposure to benzodiazepines
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
Legemiddel: Haloperidol
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
Andre navn:
  • Haldol
Aktiv komparator: Haloperidol Eligible Usual Care
Usual care
Fremgangsmåte: Usual care
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
Eksperimentell: 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
Atferdsmessig: Reduced exposure to anticholinergics

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

Fremgangsmåte: Reduced exposure to benzodiazepines
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
Aktiv komparator: Haldol Ineligible Usual Care
Usual Care
Fremgangsmåte: Usual care
May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Days Free of Delirium and Coma
Tidsramme: Admission through day 8 of stay
Admission through day 8 of stay

Sekundære resultatmål

Resultatmål
Tidsramme
Hospital Length of Stay Post Randomization
Tidsramme: Participants were followed for the duration of hospital stay, an average of 11 days
Participants were followed for the duration of hospital stay, an average of 11 days
Mortality
Tidsramme: ICU, in-hospital, 30-days post hospitalization
ICU, in-hospital, 30-days post hospitalization

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Indiana University

Samarbeidspartnere

National Institute on Aging (NIA)

Etterforskere

  • Hovedetterforsker: Malaz Boustani, MD, Indiana University School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2009

Primær fullføring (Faktiske)

1. juli 2015

Studiet fullført (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først innsendt

10. februar 2009

Først innsendt som oppfylte QC-kriteriene

10. februar 2009

Først lagt ut (Anslag)

12. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IA0145
  • R01AG034205 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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