DeliriumNCT03194360
Risk Factors of Delirium in Sequential Sedation Patients in Intensive Care Unit
An observational study of Delirium and Mechanical Ventilation, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delirium, Mechanical Ventilation, Sedation
- How many people
- 141 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2015to 15 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Intubated patients;
- Age≥18 years old;
- Anticipated Ventilation and sedation duration of at least 72 hours.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical care medicine of West China Hospital
Chengdu, Sichuan, 610041
About this study
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.
Read the 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.
- Conditions
- Delirium, Mechanical Ventilation, Sedation
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| delirium group | Not described | |
| nondelirium group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A maximum of twenty-eight days or until ICU discharge, whichever occurred first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Dec 2015
- Primary completion15 Jan 2017
- Study completion15 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194360
- Sponsor's protocol ID
- HuaxiICM
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24935517Mehta 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.
PubMed 25493968Ely 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.
PubMed 11797025Ouimet 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.
PubMed 17102966
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Delirium in Sequential Sedation Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03194360
- Acronym / sponsor ID
- HuaxiICM
- Conditions
- Delirium, Mechanical Ventilation, Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- 15 Jan 2017 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirium group | – | – |
| nondelirium group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Intubated patients;
- Age≥18 years old;
- Anticipated Ventilation and sedation duration of at least 72 hours.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Results publication: PubMed 24935517Zhou 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.
- Results publication: PubMed 25493968Mehta 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.
- Results publication: PubMed 11797025Ely 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.
- Results publication: PubMed 17102966Ouimet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Mechanical Ventilation, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium assessment in Sequential Sedation Patients (time frame: A maximum of twenty-eight days or until ICU discharge, whichever occurred first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194360, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.