Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00562

2 Trial Registration Date

2017-09-05

i Registration Status

Prospective

3 Secondary IDs

CREC ref. no. 2017.303

4 Source(s) of Funding

Department of Anaesthesia and Intensive Care, CUHK

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Andrew Tse

ii Address

General office,
4/F Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,
New Territories, Hong Kong

iii Phone

3505 2735

iv Email

andrewhwtse@link.cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, CUHK

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Andrew Tse

ii Address

General office,
4/F Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,
New Territories, Hong Kong

iii Phone

3505 2735

iv Email

andrewhwtse@link.cuhk.edu.hk

v Affiliation

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

External validation of pharmacokinetic models of prolonged infusion of dexmedetomidine in adult critically ill patients

10 Public Title

Pharmacokinetic models of prolonged infusion of dexmedetomidine in critically ill patients

i Public Title in Chinese 研究名稱

在成年危重病人中使用延長輸注右美托咪定注射液的藥代動力學模型的外部驗證

11 Short Title (Optional)

Pharmacokinetic models of prolonged infusion of dexmedetomidine in critically ill patients

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-07-31

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.303

14 Medical Condition Being Studied

Critical illness

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Dexmedetomidine

iii Dosage form of the intervention

Intravenous

iv Dosage of the intervention

0.1-0.7 mcg/kg/hr

v Duration of the intervention

Upto 2 weeks

vi Frequency of the intervention

Continuous infusion

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

All patients admitted to the Prince of Wales Hospital in Hong Kong expecting to requiring prolonged sedation for more than 24 hours but less than 2 weeks of dexmedetomidine for mechanical ventilation will be included.

ii Exclusion Criteria

The exclusion criteria will include the following: history of intolerance to dexmedetomidine, use of centrally acting α2-agonsits or antagonists (eg. clonidine), need for continuous muscle relaxation, uncompensated circulatory failure (mean arterial pressure < 55mm Hg despite vasopressors and inotropes), severe bradycardia (heart rate < 50 beats/min), second or third degree atrioventricular block, severe hepatic impairment (bilirubin > 101 μmol/L), acute severe intracranial or spinal neurologic disorder, significant haematological, endocrine, metabolic or gastrointestinal disease, or burn injuries and other injuries requiring regular anaesthesia or surgery.

iii Age Minimum

18

iv Age Maximum

99

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

Not applicable

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-09-07

21 Target Sample Size

23

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Dexmedetomidine serum concentrations

ii The metric or method of measurement used

Blood sampling

iii The timepoint(s) of primary interest

At the start of infusion, 0, 2, 4, 7, 10, 15, 20, 30, 40 and 60 min, and then at 2, 3, 4, 6, 12, 18 and 24 hours. If the patient is still receiving the infusion, samples will be taken twice a day. At the end of dexmedetomidine infusion (time = 0 min), and again at 2, 4, 7, 10, 15, 20, 30, 40, 60 min

24 Secondary Outcome

i The Name of the outcome

Sedation score

ii The metric or method of measurement used

Richmond Agitation Sedation Scale (RASS) scores

iii The timepoint(s) of primary interest

At the start of the infusion (t = 0), 1, 2, 3, 4, 6, 12, 18, 24 h, then three time daily during infusion. After the end of dexmedetomidine infusion, RASS scores will be measured at 0, 1, 2, 3, 4, 6,12,18, 24 and 36 hours.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-02-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-09-05