Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients

April 18, 2022 updated by: Dong-Xin Wang, Peking University First Hospital

Low-Dose Dexmedetomidine for Delirium Prevention in Mechanically Ventilated Septic Patients in Intensive Care Unit: a Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial

Delirium is common in septic patients, especially those receiving mechanical ventilation in the intensive care unit (ICU). Dexmedetomidine is a highly selective α2 adrenoreceptor agonist with anxiolytic, sedative, analgesic, and anti-inflammatory effects. Use of dexmedetomidine in mechanically ventilated ICU patients is associated with less delirium and improved outcomes. However, dexmedetomidine infusion produces dose-dependent bradycardia and hypotension; these limited the use of dexmedetomidine in ICU patients. This study is designed to test the hypothesis that low-dose dexmedetomidine infusion can also reduce delirium in mechanically ventilated ICU patients with sepsis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Delirium is an acutely occurred and fluctuating disorder of consciousness, attention, and cognition. The occurrence of delirium is associated with worse outcomes including prolonged mechanical ventilation, prolonged length of stay in ICU and hospital, increased complications, higher in-hospital mortality, and evaluated medical expenses. It is also associated with worse long-term outcomes including cognitive decline, worse quality of life, and shortened long-term survival.

Dexmedetomidine is a highly selective α2 adrenoreceptor agonist with anxiolytic, sedative, analgesic, and anti-inflammatory effects. Studies showed that use of dexmedetomidine is associated with less delirium in ICU patients. Potential mechanisms may include better sleep quality, less consumption of opioids and benzodiazepines, and suppressed inflammatory response.

The incidence of sepsis in ICU patients is as high as 47.2%; 93% of septic patients relying on mechanical ventilation. Delirium is common in septic patients; the reported incidences varies from 20% to 50%. The incidence of delirium in critically ill patients with mechanical ventilation is up to 60-84%. However, the majority of mechanically ventilated ICU patients are sedated with propofol; only 10% of them are given dexmedetomidine. A main reason is that dexmedetomidine infusion is associated with dose-related bradycardia and hypotension.

In a previous study, might-time low-dose dexmedetomidine infusion (0.1 μg/kg/h) improved subjective sleep quality and reduced delirium in elderly patients admitted to ICU after surgery. In another study of ICU patients receiving mechanical ventilation, low-dose dexmedetomidine infusion (0-0.5 μg/kg/h) based on protocol sedation also reduced delirium and shortened mechanical ventilation without increasing adverse events. We hypothesized that, in ICU septic patients with mechanical ventilation, low-dose dexmedetomidine infusion (0.1-0.2 μg/kg/h) might also reduce delirium.

The purpose of this study is to investigate the effect of low-dose dexmedetomidine infusion on incidence of delirium in ICU septic patients with mechanical ventilation.

Study Type

Interventional

Enrollment (Anticipated)

116

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:

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:

  1. Aged 18 years or older;
  2. Admitted to the ICU;
  3. With expected mechanical ventilation duration ≥12 hours;
  4. Meet the diagnostic criteria of sepsis (sepsis 3.0; patient with infection and a sequential organ failure assessment score ≥2).

Exclusion Criteria:

  1. Refuse to participate in;
  2. Pregnancy;
  3. History of schizophrenia, epilepsy, parkinsonism, or myasthenia gravis;
  4. Inability to communicate (coma, profound dementia, or language barrier);
  5. Brain injury or neurosurgery;
  6. Left ventricular ejection fraction (LVEF) less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second degree or greater atrioventricular block without pacemaker;
  7. Serious hepatic dysfunction (Child-Pugh class C);
  8. Serious renal dysfunction (undergoing dialysis);
  9. With expected survival for no more than 24 hours;
  10. Allergic to dexmedetomidine;
  11. Other conditions that were considered unsuitable for study participation.

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 0.1-0.2 ug/kg/h during mechanical ventilation, for a maximum of 7 days.
Drug: Dexmedetomidine
Dexmedetomidine is infused at a rate of 0.1-0.2 μg/kg/h (0.025-0.05 ml/kg/h) from study recruitment in the ICU during mechanical ventilation, for no more than 7 days.
Other Names:
  • Dexmedetomidine hydrochloride
Placebo Comparator: Placebo group
Placebo (normal saline) is infused at a same rate as in the dexmedetomidine group during mechanical ventilation, for a maximum of 7 days.
Drug: Placebo (normal saline)
Placebo (normal saline) is infused at a rate of 0.025-0.05 ml/kg/h from study recruitment in the ICU during mechanical ventilation, for no more than 7 days.
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: Up to 7 days after enrollment
Delirium is assessed twice daily (from 06:00 to 10:00 and from 18:00 to 20:00) with the Confusion Assessment Method for the intensive care unit (CAM-ICU).
Up to 7 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation.
Time Frame: Up to 30 days after enrollment
Duration of mechanical ventilation after study enrollment.
Up to 30 days after enrollment
Length of stay in the ICU.
Time Frame: Up to 30 days after enrollment
Length of stay in the ICU after study enrollment.
Up to 30 days after enrollment
Length of stay in the hospital.
Time Frame: Up to 30 days after enrollment
Length of stay in the hospital after study enrollment.
Up to 30 days after enrollment
Incidence of non-delirium complications.
Time Frame: Up to 30 days after enrollment
Non-delirium complications are defined as newly occurred medical conditions other than delirium that required therapeutic intervention, i.e., grade 2 or higher on Clavien-Dindo classification.
Up to 30 days after enrollment
All-cause 30-day mortality
Time Frame: Up to 30 days after enrollment
All-cause 30-day mortality after study enrollment.
Up to 30 days after enrollment
30-day cognitive function
Time Frame: On the 30th day after enrollment.
Cognitive function is assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function.
On the 30th day after enrollment.
30-day quality of life
Time Frame: On the 30th day after enrollment.
Quality-of-life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
On the 30th day after enrollment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity.
Time Frame: Up to 7 days after enrollment.
Assessed twice daily (from 06:00 to 10:00 and from 18:00 to 20:00) with the Numeric Rating Scale (NRS, an 11-point scale where 0 indicated no pain and 10 indicated the worst possible pain).
Up to 7 days after enrollment.
Subjective sleep quality.
Time Frame: Up to 7 days after enrollment.
Assessment once daily (from 06:00 to 10:00) with the Numeric Rating Scale (NRS, an 11-point scale where 0 indicated the best possible sleep and 10 indicated the worst possible sleep).
Up to 7 days after enrollment.
Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).
Time Frame: Within 24 hours after enrollment.
Score of Acute Physiology and Chronic Health Evaluation II (APACHE II).
Within 24 hours after enrollment.
6-month cognitive function.
Time Frame: At the end of 6 months after enrollment.
Cognitive function is assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function.
At the end of 6 months after enrollment.
6-month quality of life.
Time Frame: At the end of 6 months after enrollment.
Quality-of-life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
At the end of 6 months after enrollment.
Overall survival
Time Frame: Up to 1 year after enrollment.
Overall survival
Up to 1 year after enrollment.
1-year cognitive function.
Time Frame: At the end of 1 year after enrollment.
Cognitive function is assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function.
At the end of 1 year after enrollment.
1-year quality of life.
Time Frame: At the end of 1 year after enrollment.
Quality-of-life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
At the end of 1 year after enrollment.

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Collaborators

Beijing Friendship Hospital
Beijing Tongren Hospital
Beijing Hospital
Beijing Shijitan Hospital, Capital Medical University
China-Japan Friendship 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)

May 28, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-241

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

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.

Clinical Trials on Sepsis

Clinical Trials on Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe