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Risk Factors of Delirium in Sequential Sedation Patients in Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT03194360
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Kang Yan, West China Hospital

Brief Summary:
Delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. Sequential sedation may reduce these adverse effects. This study aimed to evaluate incidence and risk factors for delirium in sequential sedation patients.

Condition or disease
Delirium Mechanical Ventilation Sedation

Detailed Description:

Previous studies have showed that patients under mechanical ventilation have a higher risk for experiencing delirium than nonmechanically ventilated patients (20%-50%). Its occurrence is also more frequent in elder patients. More than that, it is often hard to identify delirium by physicians, leading to unreasonable management of ICU patients.

And delirium is one of main adverse events in ventilated patients who receive long-term usage of mono-sedative. Sequential sedation may reduce these adverse effects.

However, few present studies focus on delirium in sequential sedation patients. Thus, in this study, we aimed to determine the factors of delirium in patients who received sequential sedation in ICU.


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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Risk Factors of Delirium in Sequential Sedation Patients in Intensive Care Unit
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : January 15, 2017
Actual Study Completion Date : January 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
delirium group
nondelirium group



Primary Outcome Measures :
  1. Delirium assessment in Sequential Sedation Patients [ Time Frame: A maximum of twenty-eight days or until ICU discharge, whichever occurred first. ]
    The primary outcome of this study was delirium. Patient evaluations were implemented using Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale every four hours a day for a maximum of twenty-eight days or until ICU discharge, whichever occurred first. The risk factors were analyzed using risk regression (logistic-regression). Any variables which had P<0.2 after univariable logistic-regression or potential variables associated with delirium were included for multivariable logistic-regression. P<0.05 was considered to represent statistical significance.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with an age greater than 18 years old and less than 80 years old, who were expected to receive mechanical ventilation longer than 72 hours and accepted sedation therapy were recruited on admission to the ICU.
Criteria

Inclusion Criteria:

  1. Intubated patients;
  2. Age≥18 years old;
  3. Anticipated Ventilation and sedation duration of at least 72 hours.

Exclusion Criteria:

  1. Allergy to the study drug;
  2. suspected pregnancy;
  3. gross obesity;
  4. Extremely unstable of circulatory system, such as systolic blood pressure less than 90 mm Hg despite plasma volume expansion and continuous infusions of vasopressors before the start of study drug infusion;
  5. Uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmHg or diastolic more than105 mmHg;
  6. Heart rate less than 50 bpm;
  7. Second or third degree heart block;
  8. moribund state;
  9. history of alcoholism or intake of anti-anxiety drugs or hypnotics;
  10. chronic renal failure;
  11. coma by cranial trauma or neurosurgery or unknown etiology or epileptic state;
  12. History of neuromuscular disease;
  13. unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.

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): NCT03194360


Locations
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China, Sichuan
Department of Critical care medicine of West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital

Publications of Results:
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Responsible Party: Kang Yan, Study Chair: Y Kang, Dr Critical Medicine Department,West China Hospital of Sichuan University, West China Hospital
ClinicalTrials.gov Identifier: NCT03194360     History of Changes
Other Study ID Numbers: HuaxiICM
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders