Sedative Withdrawal DeliriumPhase 4NCT02123589

The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.

A Phase 4 study testing Deep sedation(midazolam and fentanyl ), Deep and daily interruption of sedation(midazolam and fentanyl ) and Light sedation(midazolam and fentanyl ) in people with Sedative Withdrawal Delirium, run by West China Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Sedative Withdrawal Delirium
What is being tested?: Deep sedation(midazolam and fentanyl ), Deep and daily interruption of sedation(midazolam and fentanyl ) and Light sedation(midazolam and fentanyl )
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: No sites listed yet
Study dates: Apr 2014to Dec 2015
Phase: Phase 4
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
Critically ill adults whose expected time of mechanical ventilation is longer than 24 hours
Aged between 18 years old to 85 years old.

Who cannot join

Subjects with brain injury;
History of cardiopulmonary resuscitation;
Mental disability;
Taken neuromuscular blocking drugs;
Inability to exchange;
Contraindicated to midazolam or morphine;
Inconvenience to daily interruption

About this study

Official title: The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial

The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation.

Conditions: Sedative Withdrawal Delirium
Being tested: Deep sedation(midazolam and fentanyl ), Deep and daily interruption of sedation(midazolam and fentanyl ), Light sedation(midazolam and fentanyl )

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deep sedation(midazolam and fentanyl )Drug
0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; the target level of sedation,RASS score between -5 and -3
Deep and daily interruption of sedation(midazolam and fentanyl )Drug
0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl continuous intravenous infusion ; The target level of sedation,RASS score between -5 and -3. Daily interruption of sedation will be taken from the second day after admitted in ICU
Light sedation(midazolam and fentanyl )Drug
0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; The target level of sedation,RASS score between -2 and +1;

Study groups in NCT02123589
Study group	Role	What they receive
Deep sedation	Experimental	Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3 Receives: Drug: Deep sedation(midazolam and fentanyl )
Deep and daily interruption of sedation	Experimental	Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3.and from the second day after subject was admitted in ICU, daily interruption of sedation will be taken . Receives: Drug: Deep and daily interruption of sedation(midazolam and fentanyl )
Light sedation	Experimental	Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -2 and +1. Receives: Drug: Light sedation(midazolam and fentanyl )

What is being measured

The primary outcome is the main question the study is designed to answer.

The incident rate of delirium
Measured: From weaning to discharged from ICU,about 7 days.
The incident rates of PTSD
Measured: 30th day and 180th day after discharged from ICU
The duration of delirium
Measured: From weaning to discharged from ICU,about 7 days.

Secondary outcomes (9)

Incidence rate of unexpected extubation
Measured: From intubation to weaning,about 7 days
Dosage of analgesics and sedatives
Measured: From intination of analgesics and sedatives to stopping drug appication,about 7 days
The duration of mechanical ventilation
Measured: From intubation to weaning,about 7days
Duration of ICU
Measured: From admitted to ICU to discharged from ICU,about 7 days
The whole hospitalization time
Measured: From admitted to hospital to discharged from hospital,about 7 days
Patients' death rates within ICU stay
Measured: From admitted to ICU to discharged from ICU,about 7 days
Patients' death rates within hospitalized stay
Measured: From admitted to hospital to discharged from hospital,about 7 days
The cost in ICU
Measured: From admitted to ICU to discharged from ICU,about 7 days
The total cost in hospital
Measured: From admitted to hospital to discharged from hospital,about 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Dec 2015

First posted25 Apr 2014 (estimated)
Study startApr 2014
Primary completionMay 2015 (estimated)
Study completionDec 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sedative Withdrawal 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02123589
Sponsor's protocol ID: West ChinaH Sedation
Status last verified: Apr 2014
First submitted: 22 Apr 2014
Last updated: 25 Apr 2014
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial
ClinicalTrials.gov ID: NCT02123589
Acronym / sponsor ID: West ChinaH Sedation
Conditions: Sedative Withdrawal Delirium
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: West China HospitalUniversity, hospital or other
Study start: Apr 2014
Primary completion: May 2015 (estimated)
Study completion: Dec 2015 (estimated)
First posted: 25 Apr 2014 (estimated)
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.

The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Deep sedation	Experimental	Drug: Deep sedation(midazolam and fentanyl )Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3
Deep and daily interruption of sedation	Experimental	Drug: Deep and daily interruption of sedation(midazolam and fentanyl )Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3.and from the second day after subject was admitted in ICU, daily interruption of sedation will be taken .
Light sedation	Experimental	Drug: Light sedation(midazolam and fentanyl )Injection of 0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -2 and +1.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Written informed consent
Critically ill adults whose expected time of mechanical ventilation is longer than 24 hours
Aged between 18 years old to 85 years old.

Key exclusion criteria (7 listed)

Subjects with brain injury;
History of cardiopulmonary resuscitation;
Mental disability;
Taken neuromuscular blocking drugs;
Inability to exchange;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Deep sedation(midazolam and fentanyl )0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; the target level of sedation,RASS score between -5 and -3	Drug	Deep sedation
Deep and daily interruption of sedation(midazolam and fentanyl )0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl continuous intravenous infusion ; The target level of sedation,RASS score between -5 and -3. Daily interruption of sedation will be taken from the second day after admitted in ICU	Drug	Deep and daily interruption of sedation
Light sedation(midazolam and fentanyl )0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; The target level of sedation,RASS score between -2 and +1;	Drug	Light sedation

Primary outcome

The incident rate of delirium
Time frame: From weaning to discharged from ICU,about 7 days.
The incident rates of PTSD
Time frame: 30th day and 180th day after discharged from ICU
The duration of delirium
Time frame: From weaning to discharged from ICU,about 7 days.

9 secondary outcomes

Incidence rate of unexpected extubation
Time frame: From intubation to weaning,about 7 days
Dosage of analgesics and sedatives
Time frame: From intination of analgesics and sedatives to stopping drug appication,about 7 days
The duration of mechanical ventilation
Time frame: From intubation to weaning,about 7days
Duration of ICU
Time frame: From admitted to ICU to discharged from ICU,about 7 days
The whole hospitalization time
Time frame: From admitted to hospital to discharged from hospital,about 7 days
Patients' death rates within ICU stay
Time frame: From admitted to ICU to discharged from ICU,about 7 days
Patients' death rates within hospitalized stay
Time frame: From admitted to hospital to discharged from hospital,about 7 days
The cost in ICU
Time frame: From admitted to ICU to discharged from ICU,about 7 days
The total cost in hospital
Time frame: From admitted to hospital to discharged from hospital,about 7 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.

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.

Questions about this trial

What is this clinical trial studying?

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 7 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: status not confirmed, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

The incident rate of delirium (time frame: From weaning to discharged from ICU,about 7 days.). The study lists 3 primary outcomes in all. 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 NCT02123589.

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 25 Apr 2014.