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

NCT ID: NCT03194360

Last Updated: 2017-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-01

Study Completion Date

2017-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delirium Mechanical Ventilation Sedation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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delirium group

No interventions assigned to this group

nondelirium group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kang Yan

Study Chair: Y Kang, Dr Critical Medicine Department,West China Hospital of Sichuan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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Zhou Y, Jin X, Kang Y, Liang G, Liu T, Deng N. Midazolam and propofol used alone or sequentially for long-term sedation in critically ill, mechanically ventilated patients: a prospective, randomized study. Crit Care. 2014 Jun 16;18(3):R122. doi: 10.1186/cc13922.

Reference Type RESULT
PMID: 24935517 (View on PubMed)

Mehta S, Cook D, Devlin JW, Skrobik Y, Meade M, Fergusson D, Herridge M, Steinberg M, Granton J, Ferguson N, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Mallick R, Reynolds S, Keenan S, Burry L; SLEAP Investigators; Canadian Critical Care Trials Group. Prevalence, risk factors, and outcomes of delirium in mechanically ventilated adults. Crit Care Med. 2015 Mar;43(3):557-66. doi: 10.1097/CCM.0000000000000727.

Reference Type RESULT
PMID: 25493968 (View on PubMed)

Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.

Reference Type RESULT
PMID: 11797025 (View on PubMed)

Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.

Reference Type RESULT
PMID: 17102966 (View on PubMed)

Other Identifiers

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HuaxiICM

Identifier Type: -

Identifier Source: org_study_id

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