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

NCT03194360 | Completed DMC

• 1 other identifier: HuaxiICM
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Mechanical Ventilation; Sedation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

delirium group

nondelirium group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Allergy to the study drug;
• suspected pregnancy;
• gross obesity;
• 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;
• Uncontrolled abnormal hypertension, such as systolic blood pressure more than 180 mmHg or diastolic more than105 mmHg;
• Heart rate less than 50 bpm;
• Second or third degree heart block;
• moribund state;
• history of alcoholism or intake of anti-anxiety drugs or hypnotics;
• chronic renal failure;
• coma by cranial trauma or neurosurgery or unknown etiology or epileptic state;
• History of neuromuscular disease;
• unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (4)

• 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.

  PMID: 24935517 RESULT

• 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.

  PMID: 25493968 RESULT

• 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.

  PMID: 11797025 RESULT

• 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.

  PMID: 17102966 RESULT

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Chair: Y Kang, Dr Critical Medicine Department,West China Hospital of Sichuan University

Study Record Dates

• First Submitted: June 17, 2017
• First Posted: June 21, 2017
• Study Start: December 1, 2015
• Primary Completion: January 15, 2017
• Study Completion: January 15, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)