Centre For Clinical Research And Biostatistics (CCRB)

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Trial History Detail on 2018-12-05

Form

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00622

2 Trial Registration Date

2018-09-05

i Registration Status

Prospective

3 Secondary IDs

Joint CUHK-NTEC Clinical Research Ethics Committee 2018.227

4 Source(s) of Funding

None

5 Primary Sponsor

Department of Anaesthesia and Intensive Care

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Lowell Ling

ii Address

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

iii Phone

3505 2735

iv Email

lowell.ling@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

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

i Name

Lowell Ling

ii Address

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

iii Phone

3505 2735

iv Email

lowell.ling@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

The MOSAICS II Study (Management of Sepsis in Asia's Intensive Care unitS): A prospective observational cohort study

10 Public Title

The MOSAICS II Study (Management of Sepsis in Asia's Intensive Care unitS): A prospective observational cohort study

i Public Title in Chinese 研究名稱

亞洲深切治療學膿毒症病率及治療學

11 Short Title (Optional)

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?

2018-07-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.227

14 Medical Condition Being Studied

sepsis

15 Intervention

i Types of intervention

Other

Please specify

This is not an intervention trial.

ii Description/ name of Intervention/article

This is not an intervention trial.

iii Dosage form of the intervention

This is not an intervention trial.

iv Dosage of the intervention

This is not an intervention trial.

v Duration of the intervention

This is not an intervention trial.

vi Frequency of the intervention

This is not an intervention trial.

16 Comparative Treatments

i Description/ name of comparative treatments

This is not an intervention trial.

ii Dosage form of the comparative treatments

This is not an intervention trial.

iii Dosage of the comparative treatments

This is not an intervention trial.

iv Duration of the comparative treatments

This is not an intervention trial.

v Frequency of the comparative treatments

This is not an intervention trial.

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

ICU patients with sepsis

ii Exclusion Criteria

Patients in paediatric ICUs, neurosurgical ICUs, coronary and cardiothoracic ICUs.

iii Age Minimum

18

iv Age Maximum

999

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

observational trial

vi Study Objectives (Optional)

To determine the prevalence of sepsis defined by the Sepsis-3 guidelines as a reason for ICU admission in Asia, as well as its causes and outcomes

20 Anticipated trial start date

2019-01-09

21 Target Sample Size

200 in Hong Kong

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

prevalence of sepsis defined by the Sepsis-3 definition as reason for admission to ICU in Asia

ii The metric or method of measurement used

number of patients with sepsis per population

iii The timepoint(s) of primary interest

four time points: 9 Jan 2019, 3 April 2019, 3 July 2019, 9 Oct 2019

24 Secondary Outcome

i The Name of the outcome

time to management of sepsis

ii The metric or method of measurement used

time to management goals from presentation

iii The timepoint(s) of primary interest

four time points: 9 Jan 2019, 3 April 2019, 3 July 2019, 9 Oct 2019

Secondary Outcome

i The Name of the outcome

prevalence, causes, outcomes, and management of sepsis in Asian ICUs in high, middle, and low-income countries

ii The metric or method of measurement used

diagnosis frequency, mortality, ICU length of stay

iii The timepoint(s) of primary interest

four time points: 9 Jan 2019, 3 April 2019, 3 July 2019, 9 Oct 2019

Secondary Outcome

i The Name of the outcome

prevalence and outcomes of sepsis as a result of malaria, dengue, tuberculosis, cholera, and Salmonella infections, as well as culture-negative sepsis

ii The metric or method of measurement used

number of patients with each type sepsis cause per population

iii The timepoint(s) of primary interest

four time points: 9 Jan 2019, 3 April 2019, 3 July 2019, 9 Oct 2019

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-12-06

27 Primary Registry and Trial Identifying Number

ChiCTR1800018534

28 Date of Registration in Primary Registry

2018-09-05

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