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Delirium Prevention in Patients From the Intensive Care Unit (DELA) (DELA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215745
Recruitment Status : Unknown
Verified October 2017 by Universidad de Santander.
Recruitment status was:  Recruiting
First Posted : July 12, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Universidad de Santander

Brief Summary:
"To determine the efficacy of program of prevention of delirium in critically ill patients from the intensive care units of Bucaramanga and Floridablanca. Methods: The study will be a randomized controlled clinical trial in 600 critically ill patients recruited at 24 hours from arrival on the intensive care units of Bucaramanga and Floridablanca, without delirium, with ≥50% in the PREDELIRIC scale score, who comply with the inclusion and exclusion. The patients will be randomized in blocks to one of the two groups, intervention group (delirium prevention program, n=200) with control group (usual care; n= 400), the study will compare the incidence of delirium in both groups. Patients will be followed every day with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) until the patient presents delirium, exit to hospitalization or death. Delirium prevention program includes individualized nonpharmacological interventions such as multisensory stimulation, cognitive stimulation, activate the functional and family involvement. The study has received ethical approval from the University of Santander"

Condition or disease Intervention/treatment Phase
Hypoactive Delirium Hyperactive Delirium Delirium of Mixed Origin Behavioral: Delirium prevention program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial Randomized, Double-blind, Controlled of Delirium Prevention Program in Patients From the Intensive Care Unit Los Comuneros Hospital University of Bucaramanga, Colombia
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Delirium prevention program
Delirium prevention program involved a non-pharmacologic preventive interventions that will be focused in: Delirium prevention program includes individualized non-pharmacological interventions such as multisensory stimulation, cognitive stimulation, activate the functional and family involvement.
Behavioral: Delirium prevention program
Delirium prevention program Placard with the names of the care team and the calendar days; cognitively stimulating activities three times a day. Pictures, radio, robe. Visual aids large print books, with daily reinforcement of use Maintain adequate lighting opening blinds and curtains during the day, and darken their environment at night. Dissipation wax and special techniques of communication, with daily reinforcement of these adaptations. Go to the patient by name and tone of voice appropriate. Always listen. Use simple and clear language, face-to-face. Avoid excessive familiarity and childish. Promote family involvement in self-care and caregivers and the reorientation of the patient, contact with extended family during the stay.

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. Delirium [ Time Frame: Within the first 30 days after admission at ICW ]
    For the measurement of delirium will be with the instrument Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) version in spanish.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be older than 18 years
  • To have 24 hours of stay from the ingress to the intensive care unit
  • To expire with the criteria of intensive care unit defined by the investigative group (it presents itself with support, with invasive mechanical ventilation.
  • Patient without delirium in the revenue
  • Patients who present a percentage of prediction bigger than 50% according to the model PREDELIRIC

Exclusion Criteria:

  • Patients who scale of sedation RASS is applied and have like result of +4 and +5( scale that is applied systematically to the patient in intensive care unit)
  • Subjects with cognitive deficit or previous mental illness
  • Patients with precedents previous to delirium or in which the delirium measurement could be affected by its base condition
  • Patients with alcoholism precedents.
  • To be at the moment of the application of the instruments under substances that limit its skill to communicate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215745


Contacts
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Contact: Claudia C Torres, RN, MSc 57-7-6516500 ext 1221 claudiaconsuelo@yahoo.com
Contact: Astrid N Páez, RN, MSc 57-7-6516500 ext 1221 nathaliapaez1@hotmail.com

Locations
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Colombia
Los Comuneros Hospital University of Bucaramanga Recruiting
Bucaramanga, Santander, Colombia, 68006
Contact: Claudia C Torres, MSc    57-6516500 ext 1221    claudiaconsuelo@yahoo.com   
Contact: Astrid N Páez, Msc    57-6516500 ext 1221    nathaliapaez1@hotmail.com   
Sponsors and Collaborators
Universidad de Santander
Investigators
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Principal Investigator: Claudia C Torres, RN, MSc Universidad de Santander
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad de Santander
ClinicalTrials.gov Identifier: NCT03215745    
Other Study ID Numbers: 012-2014
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad de Santander:
Delirium
Critical Care
Prevention & control
Clinical Trial
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders