- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805645
Risk Factors for Mortality for COVID-19 Admitted to an Intensive Care Unit (ICUCOVID-KK)
August 30, 2023 updated by: Clinical Research Centre, Malaysia
Clinical Characteristics & Risk Factors for Mortality of COVID-19 Patients Admitted Into Intensive Care Unit in Hospital Queen Elizabeth
Studying clinical characterization of critically ill COVID-19 patients in a single center Studying Risk factors for Day 28 Mortality in COVID-19 patients admitted to intensive care unit
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
An observational study looking into clinical characterization of the novel Coronavirus Disease 2019 (COVID-19) in patients admitted, critically ill, into Intensive Care Unit of Hospital Queen Elizabeth between 1st October 2020 until 31st January 2021.
Analysis also would be looking into the risk factors into Day 28 mortality of these patients
Study Type
Observational
Enrollment (Actual)
50
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
-
-
-
Kota Kinabalu, Malaysia
- Hospital Queen Elizabeth
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021, which confirmed to have via PCR testing or Rapid Test Antigen are positive for PCR
Description
Inclusion Criteria:
- All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021
- Confirmed COVID-19 Positive using RT-PCR or RTK-Ag either before or during admission in ICU
Exclusion Criteria:
- Patients that were admitted in ICU suspected to have COVID-19 and died in ICU which subsequently to be COVID-19 negative
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-Survivors
Participants who had Critically-ill COVID-19 and admitted to the Intensive Care Unit which died before or on day 28 post ICU admission
|
No intervention as this study is a Retrospective Cohort Observational
|
|
Survivors
Participants who had Critically-ill COVID-19 and admitted to the Intensive Care Unit whom are still alive on day 28 post ICU admission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 28 days
|
Died before or on Day 28 after ICU admission
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen supplementation requirement
Time Frame: day 28
|
Requirement of oxygen supplementation on day 28 after icu admission
|
day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kean Khang Fong, Hospital Queen Elizabeth, Malaysia
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)
April 1, 2021
Primary Completion (Actual)
April 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
March 16, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
September 1, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICUCOVID-KK
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 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.
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