Low-dose Dexmedetomidine in Mechanically Ventilated ICU Patients

April 19, 2022 updated by: Dong-Xin Wang, Peking University First Hospital

Low-dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Patients in Intensive Care Unit: a Multicenter, Randomised, Double-blinded, Placebo-controlled Trial

For patients undergoing mechanical ventilation, light sedation is better than deep sedation for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of mechanical ventilation, and decreased mortality. In a recent study of the investigators, low-dose dexmedetomidine without sedative effects (0.1 ug/kg/h) improved sleep quality and reduced the incidence of delirium in elderly patients admitted to the ICU after surgery. The investigators hypothesize that, for ICU patients with prolonged mechanical ventilation, low-dose dexmedetomidine infusion (0.1 ug/kg/h) may also be effective in decreasing delirium. The purpose of this study is to investigate whether low-dose dexmedetomidine infusion can reduce the incidence of delirium in ICU patients with prolonged duration of mechanical ventilation (>= 24 hours).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Delirium is an acutely occurred and transient brain dysfunction characterized with cognitive dysfunction, lowered consciousness, disturbed attention, abnormal psychoactivity, and disordered sleep-wake rhythm. Delirium is frequent in mechanically ventilated patients in the intensive care unit (ICU), with reported incidences up to 70% or 87%. Possible reasons leading to delirium include the intervention-heavy environment of the ICU, mechanical ventilation and sleep disturbances. The occurrence of delirium is associated with worse outcomes including prolonged mechanical ventilation and ICU stay, increased complications, prolonged hospital stay, higher mortality, and elevated medical expenses. It is also associated with worse long-term outcomes including declined cognitive function, lowered life quality, and elevated long-term mortality.

Dexmedetomidine is a high selective alpha-2 adrenoceptor agonist with anxiolytic, sedative and analgesic effects. When used for sedation in mechanically ventilated patients (dose range 0.2-1.4 ug/kg/h), it reduces the consumption of other sedatives and analgesics, ameliorates the rhythm and structure of sleep, and decreases the occurrence of delirium. In recent studies of the investigators, low-dose dexmedetomidine infusion (0.1 ug/kg/h) ameliorated sleep quality; for elderly patients admitted to the ICU after surgery, prophylactic low-dose dexmedetomidine infusion reduced the incidence of delirium (for patients with mechanical ventilation: 28.8% with placebo vs. 11.5% with dexmedetomidine, P<0.0001; for patients without mechanical ventilation: 15.1% with placebo vs. 6.3% with dexmedetomidine, P=0.014).

For patients undergoing mechanical ventilation, light sedation is better than deep sedation for the outcomes, which is manifested as shortened length of ICU stay, shortened duration of mechanical ventilation, and decreased mortality. Some authors even reported that no sedation (analgesia only) provides better outcome than light sedation, because it further shortens the durations of mechanical ventilation and ICU stay. In the above studies of the investigators, the recruited patients were less severe because the Acute Physiology and Chronic Health Evaluation II (APACHE II) score was low (mean score from 10.2 to 10.6) and the duration of mechanical ventilation was short (median 6.9 hours in the control group). The investigators hypothesize that, for ICU patients with prolonged mechanical ventilation, low-dose dexmedetomidine infusion (0.1 ug/kg/h) may also be effective in improving sleep and decreasing delirium. The purpose of this study is to investigate whether low-dose dexmedetomidine infusion can reduce the incidence of delirium in ICU patients with prolonged duration of mechanical ventilation (>= 24 hours).

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 18 years or older;
  • admitted to the ICU;
  • with expected duration of mechanical ventilation of more than 24 hours.

Exclusion Criteria:

  • refused to participate;
  • aged less than 18 years;
  • pregnant;
  • preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
  • inability to communicate in the preoperative period (coma, profound dementia, or language barrier);
  • brain injury or neurosurgery;
  • known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second degree or greater atrioventricular block without pacemaker;
  • severe hepatic dysfunction (Child-Pugh class C);
  • severe renal dysfunction (undergoing dialysis before surgery);
  • less likely to survive for more than 24 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
Dexmedetomidine is infused at a rate of 0.1 ug/kg/h for a maximum of 3 days.
Drug: Dexmedetomidine
Dexmedetomidine is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h (0.1 μg/kg per h) from study recruitment in the ICU for no more than 72 hours.
Other Names:
  • Dexmedetomidine hydrochloride
Placebo Comparator: Placebo group
Placebo (normal saline) is infused at a same rate as in the dexmedetomidine group for a maximum of 3 days.
Drug: Placebo (normal saline)
Placebo (normal saline) is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h from study recruitment in the ICU for no more than 72 hours.
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium within the first 7 days after enrollment
Time Frame: From enrollment until 7 days.
Assessment twice daily (in the morning from 0600 h to 1000 h and in the evening from 1800 h to 2000 h) with the Confusion Assessment Method for the ICU (CAM-ICU).
From enrollment until 7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: From enrollment until extubation or 30 days.
Duration of mechanical ventilation after study enrollment.
From enrollment until extubation or 30 days.
Length of stay in the ICU
Time Frame: From enrollment until ICU discharge or 30 days.
Length of stay in the ICU after study enrollment.
From enrollment until ICU discharge or 30 days.
Length of stay in the hospital
Time Frame: From enrollment until hospital discharge or 30 days.
Length of stay in the hospital after study enrollment.
From enrollment until hospital discharge or 30 days.
Occurrence of non-delirium complications
Time Frame: From enrollment until 30 days.
Occurrence of complications other than delirium after study enrollment.
From enrollment until 30 days.
All-cause 30-day mortality
Time Frame: On the 30th day after enrollment.
All-cause 30-day mortality after study enrollment.
On the 30th day after enrollment.
30-day cognitive function
Time Frame: On the 30th day after enrollment.
Assessed with the Telephone Interview of Cognitive Status-Modified (TICS-m).
On the 30th day after enrollment.
30-day life quality
Time Frame: On the 30th day after enrollment.
Assessed with the WHOQOL-Bref.
On the 30th day after enrollment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: From enrollment until 7 days.
Assessed twice daily (in the morning from 0600 h to 1000 h and in the evening from 1800 h to 2000 h) with the Numeric Rating Scale (NRS, an 11 point scale where 0 indicated no pain and 10 indicated the worst possible pain).
From enrollment until 7 days.
Subjective sleep quality
Time Frame: From enrollment until 7 days.
Assessed in the morning with the NRS (an 11 point scale where 0 indicated the best possible sleep and 10 indicated the worst possible sleep).
From enrollment until 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2017

Primary Completion (Actual)

August 21, 2017

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017[1319]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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