- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06155981
Coca-Cola Zero (®) Consumption on Night-call Inpatient Course and Mortality
February 17, 2024 updated by: Kwan Yu Heng, Duke-NUS Graduate Medical School
Coke Zero for the Zero: A Study Examining the Effect of Coke Zero Consumption on Night Call Inpatient Course and Mortality
The purpose of this study is to determine the effect of coke zero consumption by night-call staffs on inpatient admission and mortality, and total sleep duration during the night-call duty.
Coke Zero is a soft drink that is widely popular within the medical community, carrying the meaning of "zero", which to some, signifies the minimal level of morbidity and mortality that will occupy the on-call the night staffs.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Previous studies have demonstrated that superstitions among the medical community have been prevalent and staffs regularly engaged in conforming to the superstitions because of their associations with workload, inpatient admissions and mortality.
As such, the current study aims to evaluate whether the consumption of Coke Zero has an effects on patient admissions and mortality and the eventfulness of the night-call duties.
Study Type
Interventional
Enrollment (Estimated)
160
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
- Name: Yu Heng Kwan, MD, PhD
- Phone Number: 006590231226
- Email: phakyh@nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 169608
- Singapore General Hospital
-
Contact:
- Yu Heng Kwan, MD, PhD
- Phone Number: 006590231226
- Email: phakyh@nus.edu.sg
-
-
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
Yes
Description
Inclusion Criteria:
• Doctors on the night-call roster at Singapore General Hospital
Exclusion Criteria
• Other allied health professionals or medical students
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coke Zero Arm
The participant will be given a Coke Zero before each night-call duty for consumption.
|
Coca-Cola Zero Sugar drink will be given.
|
Active Comparator: Coke Arm
The participant will be given a Coke before each night-call duty for consumption.
|
Coca-Cola drink will be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inpatient Mortality
Time Frame: The designated night-call doctor's shift from 5PM to 8AM the next day
|
For patients assigned under the designated night-call doctor's care
|
The designated night-call doctor's shift from 5PM to 8AM the next day
|
Inpatient general ward admission
Time Frame: The designated night-call doctor's shift from 5PM to 8AM the next day
|
For patients assigned under the designated night-call doctor's care
|
The designated night-call doctor's shift from 5PM to 8AM the next day
|
Inpatient High Dependency/Intensive Care Unit Admission
Time Frame: The designated night-call doctor's shift from 5PM to 8AM the next day
|
For patients assigned under the designated night-call doctor's care
|
The designated night-call doctor's shift from 5PM to 8AM the next day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hours of sleep during the night-call
Time Frame: The designated night-call doctor's shift from 5PM to 8AM the next day
|
For the designated night-call doctor's care
|
The designated night-call doctor's shift from 5PM to 8AM the next day
|
Hours of shift during the night-call
Time Frame: The designated night-call doctor's shift from 5PM to 8AM the next day
|
For the designated night-call doctor's care
|
The designated night-call doctor's shift from 5PM to 8AM the next day
|
Number of steps walked by the night-call staff during the night-call
Time Frame: The designated night-call doctor's shift from 5PM to 8AM the next day
|
For the designated night-call doctor's care
|
The designated night-call doctor's shift from 5PM to 8AM the next day
|
Level of alertness of the night-call staff after the night-call
Time Frame: The designated night-call doctor's shift from 5PM to 8AM the next day
|
Measured using the Karolinska Sleepiness Scale and the Epworth Sleepiness Scale
|
The designated night-call doctor's shift from 5PM to 8AM the next day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yu Heng Kwan, MD, PhD, SingHealth Internal Medicine Residency
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.
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)
January 10, 2024
Primary Completion (Actual)
February 2, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
November 18, 2023
First Submitted That Met QC Criteria
November 26, 2023
First Posted (Actual)
December 5, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 17, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Anesthetics, Local
- Dopamine Uptake Inhibitors
- Vasoconstrictor Agents
- Cocaine
Other Study ID Numbers
- DukeNushssrkyh-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is currently no plan to share IPD to other researchers.
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.
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