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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194360
• Other study ID #: HuaxiICM
• Status: Completed
• Phase: N/A
• First received: June 17, 2017
• Last updated: June 20, 2017
• Start date: December 1, 2015
• Est. completion date: January 15, 2017

Study information

• Verified date: June 2017
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 15, 2017
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Mechanical Ventilation
• Sedation

Locations

Country	Name	City	State
China	Department of Critical care medicine of West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Epub 2001 Nov 8. — View Citation

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 Tr — View Citation

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. Epub 2006 Nov 11. — View Citation

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/c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium assessment in Sequential Sedation Patients	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.	A maximum of twenty-eight days or until ICU discharge, whichever occurred first.