Coca-Cola Zero (®) Consumption on Night-call Inpatient Course and Mortality

• Sponsor: Duke-NUS Graduate Medical School (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06155981
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mortality	Other: Coke Zero; Other: Coke	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two groups of night-call staffs will be receiving different interventions.Two groups of night-call staffs will be receiving different interventions.
• Masking: Single (Participant)
• Masking Description: Participants will not be aware of the type of drink they receive.
• Primary Purpose: Other
• Official Title: Coke Zero for the Zero: A Study Examining the Effect of Coke Zero Consumption on Night Call Inpatient Course and Mortality
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coke Zero Arm The participant will be given a Coke Zero before each night-call duty for consumption.	Other: Coke Zero; 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.	Other: Coke; Coca-Cola drink will be given.

Outcome Measures

Primary Outcome Measures

1. Inpatient Mortality [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

2. Inpatient general ward admission [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

3. Inpatient High Dependency/Intensive Care Unit Admission [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

Secondary Outcome Measures

1. Hours of sleep during the night-call [The designated night-call doctor's shift from 5PM to 8AM the next day]

   For the designated night-call doctor's care

2. Hours of shift during the night-call [The designated night-call doctor's shift from 5PM to 8AM the next day]

   For the designated night-call doctor's care

3. Number of steps walked by the night-call staff during the night-call [The designated night-call doctor's shift from 5PM to 8AM the next day]

   For the designated night-call doctor's care

4. Level of alertness of the night-call staff after the night-call [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Doctors on the night-call roster at Singapore General Hospital

Exclusion Criteria

• Other allied health professionals or medical students

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Singapore General Hospital	Singapore		Singapore	169608

Sponsors and Collaborators

• Duke-NUS Graduate Medical School

Investigators

• Principal Investigator: Yu Heng Kwan, MD, PhD, SingHealth Internal Medicine Residency

Study Documents (Full-Text)

None provided.

More Information

Publications

• Tan MH, Lee Z, Ng B, Sim ES, Chua YY, Tien M, Ooi CJ. The Tao of bao: a randomised controlled trial examining the effect of steamed bun consumption on night-call inpatient course and mortality. Ann Acad Med Singap. 2008 Mar;37(3):255-3.

• Responsible Party: Kwan Yu Heng, Principle Investigator, Duke-NUS Graduate Medical School
• ClinicalTrials.gov Identifier: NCT06155981
• Other Study ID Numbers: DukeNushssrkyh-01
• First Posted: Dec 5, 2023
• Last Update Posted: Dec 5, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kwan Yu Heng, Principle Investigator, Duke-NUS Graduate Medical School: Coke Zero; Night-call Staffs; Inpatient Admission; Inpatient Course; Inpatient Mortality
• Additional relevant MeSH terms: Cocaine

Study Results

No Results Posted as of Dec 5, 2023