Treatment of Hypoactive Delirium and Outcome Measures

NCT02345902 | Unknown Phase 3 DMC

• 1 other identifier: InstitutoNCMNSZ
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Haloperidol and Non-Pharmacologic Treatment are recognized treatments for delirium. This study will evaluate which is the best treatment for hypoactive delirium.

Conditions

Hypoactive Delirium

Outcome Measures

Primary Outcomes (1)

• Change in delirium severity

  Reduction of 50% from the basal DOSS score

  Participants will be followed at an expected average of nine days

Secondary Outcomes (7)

• Necessity of additional open label haloperidol doses to control delirium symptoms

  Participants will be followed at an expected average of nine days

• Delirium duration

  Participants will be followed at an expected average of nine days

• Perceived stress

  At 24 hours after delirium remission

• Posttraumatic stress disorder

  At 6 months after delirium remission

• Cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA) <24 points

  At 6 months after delirium remission

Study Arms (2)

Haloperidol and non-pharmacologic

EXPERIMENTAL

Haloperidol 1.25mg PO q. d. during nine days Non-pharmacologic measures: A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)

Drug: Haloperidol; Other: non-pharmacologic measures

Placebo and non-pharmacologic

ACTIVE COMPARATOR

Placebo 1.25 mg PO q.d during nine days. Non-pharmacologic measures: A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)

Other: Placebo; Other: non-pharmacologic measures

Interventions

Haloperidol DRUG

haloperidol 1.25 mg P.O q.d

Also known as: haloperil

Haloperidol and non-pharmacologic

Placebo OTHER

placebo 1.25 mg P.O q.d

Placebo and non-pharmacologic

non-pharmacologic measures OTHER

A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)

Haloperidol and non-pharmacologic; Placebo and non-pharmacologic

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients who fulfill criteria for delirium according to CAM and DOSS
• Patients in hospitalization who are not receiving treatment for delirium
• Patients without treatment with antipsychotics for any other reason
• Patients whose legally proxy accepts to participate

You may not qualify if:

• Patients who have received pharmacologic treatment for delirium
• Patients with a corrected QT interval prolongation
• Patients who receive antipsychotics for any other reason
• Patients in another age group
• Patients whose legally proxy does not accept to participate
• Patients with dementia
• Patients with Parkinson disease
• Patients with arrythmias
• Patients with language or hearing disorders that impede communication
• Patients hospitalized in the Intensive Care Unit
• Patients who are receiving benzodiazepines and anticholinergics
• Patients with dopamine agonists or antagonists
• Patients who develop a severe neurologic disease

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Department of Neurology and Psychiatry. Instituto Nacional de Ciencias Médicas y Nutrición

Mexico City, Mexico City, 14000, Mexico

RECRUITING

Related Publications (16)

• Khan BA, Zawahiri M, Campbell NL, Fox GC, Weinstein EJ, Nazir A, Farber MO, Buckley JD, Maclullich A, Boustani MA. Delirium in hospitalized patients: implications of current evidence on clinical practice and future avenues for research--a systematic evidence review. J Hosp Med. 2012 Sep;7(7):580-9. doi: 10.1002/jhm.1949. Epub 2012 Jun 8.

  PMID: 22684893 BACKGROUND

• McCusker J, Cole M, Dendukuri N, Belzile E, Primeau F. Delirium in older medical inpatients and subsequent cognitive and functional status: a prospective study. CMAJ. 2001 Sep 4;165(5):575-83.

  PMID: 11563209 BACKGROUND

• Davis DH, Muniz Terrera G, Keage H, Rahkonen T, Oinas M, Matthews FE, Cunningham C, Polvikoski T, Sulkava R, MacLullich AM, Brayne C. Delirium is a strong risk factor for dementia in the oldest-old: a population-based cohort study. Brain. 2012 Sep;135(Pt 9):2809-16. doi: 10.1093/brain/aws190. Epub 2012 Aug 9.

  PMID: 22879644 BACKGROUND

• Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

  PMID: 22762316 BACKGROUND

• Griffiths RD, Jones C. Delirium, cognitive dysfunction and posttraumatic stress disorder. Curr Opin Anaesthesiol. 2007 Apr;20(2):124-9. doi: 10.1097/ACO.0b013e3280803d4b.

  PMID: 17413395 BACKGROUND

• Breitbart W, Gibson C, Tremblay A. The delirium experience: delirium recall and delirium-related distress in hospitalized patients with cancer, their spouses/caregivers, and their nurses. Psychosomatics. 2002 May-Jun;43(3):183-94. doi: 10.1176/appi.psy.43.3.183.

  PMID: 12075033 BACKGROUND

• van Munster BC, Bisschop PH, Zwinderman AH, Korevaar JC, Endert E, Wiersinga WJ, van Oosten HE, Goslings JC, de Rooij SE. Cortisol, interleukins and S100B in delirium in the elderly. Brain Cogn. 2010 Oct;74(1):18-23. doi: 10.1016/j.bandc.2010.05.010. Epub 2010 Jun 26.

  PMID: 20580479 BACKGROUND

• Milbrandt EB, Kersten A, Kong L, Weissfeld LA, Clermont G, Fink MP, Angus DC. Haloperidol use is associated with lower hospital mortality in mechanically ventilated patients. Crit Care Med. 2005 Jan;33(1):226-9; discussion 263-5. doi: 10.1097/01.ccm.0000150743.16005.9a.

  PMID: 15644675 BACKGROUND

• Adamis D, Lunn M, Martin FC, Treloar A, Gregson N, Hamilton G, Macdonald AJ. Cytokines and IGF-I in delirious and non-delirious acutely ill older medical inpatients. Age Ageing. 2009 May;38(3):326-32; discussion 251. doi: 10.1093/ageing/afp014. Epub 2009 Mar 5.

  PMID: 19269948 BACKGROUND

• Practice guideline for the treatment of patients with delirium. American Psychiatric Association. Am J Psychiatry. 1999 May;156(5 Suppl):1-20. No abstract available.

  PMID: 10327941 BACKGROUND

• Brajtman S, Wright D, Hogan DB, Allard P, Bruto V, Burne D, Gage L, Gagnon PR, Sadowski CA, Helsdingen S, Wilson K. Developing guidelines on the assessment and treatment of delirium in older adults at the end of life. Can Geriatr J. 2011 Jun;14(2):40-50. doi: 10.5770/cgj.v14i2.13. Epub 2011 Jul 7.

  PMID: 23251311 BACKGROUND

• National Clinical Guideline Centre (UK). Delirium: Diagnosis, Prevention and Management [Internet]. London: Royal College of Physicians (UK); 2010 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK65558/

  PMID: 22319805 BACKGROUND

• Inouye SK, Westendorp RG, Saczynski JS, Kimchi EY, Cleinman AA. Delirium in elderly people--authors'reply. Lancet. 2014 Jun 14;383(9934):2045. doi: 10.1016/S0140-6736(14)60994-6. No abstract available.

  PMID: 24931690 BACKGROUND

• Maclullich AM, Anand A, Davis DH, Jackson T, Barugh AJ, Hall RJ, Ferguson KJ, Meagher DJ, Cunningham C. New horizons in the pathogenesis, assessment and management of delirium. Age Ageing. 2013 Nov;42(6):667-74. doi: 10.1093/ageing/aft148. Epub 2013 Sep 25.

  PMID: 24067500 BACKGROUND

• Boettger S, Friedlander M, Breitbart W, Passik S. Aripiprazole and haloperidol in the treatment of delirium. Aust N Z J Psychiatry. 2011 Jun;45(6):477-82. doi: 10.3109/00048674.2011.543411.

  PMID: 21563866 BACKGROUND

• Friedman JI, Soleimani L, McGonigle DP, Egol C, Silverstein JH. Pharmacological treatments of non-substance-withdrawal delirium: a systematic review of prospective trials. Am J Psychiatry. 2014 Feb;171(2):151-9. doi: 10.1176/appi.ajp.2013.13040458.

  PMID: 24362367 BACKGROUND

MeSH Terms

Interventions

Haloperidol

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Erwin Chiquete, MD, PhD

  Instituto Nacional de Ciencias Médicas y Nutrición

  STUDY DIRECTOR

• Carlos Cantú, MD, PhD

  Instituto Nacional de Ciencias Médicas y Nutrición

  STUDY DIRECTOR

Central Study Contacts

Maria Carmen Flores, MD, MSc

CONTACT

54870900; mcflormir@gmail.com

Sara Aguilar, MD, MSc

CONTACT

54870900; sgan30@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: January 26, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 21, 2017

Record last verified: 2016-01

Locations

ME (1)