Effect of Daily Interruption of Continuous Sedation on Delirium, Sleep Perception in Intensive Care Unit (ICU) Patients

NCT00714194 | Completed Early Phase 1 DMC

• 1 other identifier: H41297-32404-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is an intervention study whose purpose is to determine whether daily interruption of sedative infusion contributes to the reduction of the occurrence of delirium and improves sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU) receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the study. A patient will be entered into the study after the family member has consented to have the patient participate.

Conditions

Delirium; Sleep Perception

Keywords

sedation; delirium; sleep; sedation withdrawal; ICU patients

Outcome Measures

Primary Outcomes (1)

• Delirium and sleep

  3 days in ICU

Study Arms (2)

1

OTHER

Patients in the control group will receive continuous sedative infusions without daily interruption of sedatives based on the standard clinical practice of the TICU.

Procedure: Normal continuous sedation

2

EXPERIMENTAL

Patients in the intervention group will receive daily interruption of sedative.

Other: Daily interruption of continuous sedation

Interventions

Normal continuous sedation PROCEDURE

Normal continuous sedation.

1

Daily interruption of continuous sedation OTHER

Withdrawal of normal continuous sedation with Lorazepam, Midazolam, and Propofol from 7:00 am to 8:00 am daily until continuous sedation discontinuation.

Also known as: Ativan®, Versed®, Driprivan®

2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 21 years will be recruited from a Trauma Intensive Care Unit of Puerto Rico. This unit receives critically ill patients with three or more affected body systems involved after motor vehicle accident, gunshot injury, penetrating injury, and falls.

You may not qualify if:

• Baseline neurological diseases
• Head trauma or acute neurological injury with Glasgow Coma Scale score \< 8
• Death expected within 24 hours (APACHE II ≥ 30)
• History of alcoholism
• History of drug dependence
• Deaf and blind patients

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Trauma Unit University of Puerto Rico Medical Center

San Juan, Puerto Rico

Location

MeSH Terms

Conditions

Delirium

Interventions

Lorazepam; Midazolam

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Geraldine V Padilla, PhD

  The Regents of the University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: July 14, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

PR (1)