Copeptin and Psychological Stress of Medic During COVID-19 Pandemic

Psychological Stress Clinical Trial

— COVID-19  

Official title:

Evaluation of Serum Copeptin and Psychological Stress Level Among Healthcare Providers During COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757285
• Other study ID #: 0304842
• Status: Completed
• Start date: May 10, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Psychological stress (PSS) is one of the most common problems among healthcare providers during COVID-19 pandemic. PSS influences the homeostatic equilibrium of the body, involving activation of the sympathetic nervous system and hypothalamus pituitary adrenal (HPA) axis. Copeptin; C-terminal portion of Vasopressin (AVP) precursor is stable. Nevertheless, Evidence about influence of PSS on copeptin levels is lacking. The reason we are doing this research is to determine the level of psychological stress among healthcare providers exposed to at the time of work in intensive care unit (ICU) during COVID-19 pandemic; They will be appraised every assembly for psychological stress level; before start of duty shifts (first time), one week after start (second time) and two weeks after departure from shift duties in ICU (third time) for assessment of psychological stress level and stress hormones.

Description:

A total of 70 healthcare personnel volunteers participated; 35 physicians and 35 nurses. All healthcare providers' volunteers are in good physical health, Exclusion criteria included hypertension, diabetes mellitus, obesity BMI ≥30, subjects with serum sodium ≤135 or ≥ 145 mmol /L at baseline or females receiving contraceptive pills.

During the research participants will answer a questionnaire as well as three blood samples are taken.

• In the first meeting, evaluation of participant general condition; determining BMI, blood pressure. Then a small amount of blood, equal to about two millimeters, will be taken from participant arm with a syringe. This blood will be tested for serum copeptin, cortisol (fasting morning sample). The investigator will ask participant few questions to evaluate the level of stress (as anxiety, insomnia, fear of infection through questionnaire)

• The second meeting, one week after work in ICU, another blood sample will be taken from participant and determine level of psychological stress.

• The third meeting, two weeks after leave from ICU participant blood sample will be taken from participant to determine stress hormones and determine level of psychological stress.

Duration

The research takes place over six months in total.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 37 Years

Eligibility

Inclusion Criteria:

physicians and nurses under age of 37 years in good health

Exclusion Criteria:

• body mass index above 30

• hypertension

• Diabetes mellitus

• females receiving contraceptive pills

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Diabetes Insipidus
• Hemostatic Disorder
• Hemostatic Disorders
• Psychological Stress
• Stress, Psychological

Locations

Country	Name	City	State
Egypt	Alexandria University Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Christ-Crain M, Fenske W. Copeptin in the diagnosis of vasopressin-dependent disorders of fluid homeostasis. Nat Rev Endocrinol. 2016 Mar;12(3):168-76. doi: 10.1038/nrendo.2015.224. Epub 2016 Jan 22. Review. — View Citation

McEwen BS. Protective and damaging effects of stress mediators: central role of the brain. Dialogues Clin Neurosci. 2006;8(4):367-81. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of psychological stress	- Primarily outcome determination of psychological stress among doctors and nurses working in ICU through a questionnaire before duty shifts [first time] and re-evaluate it after one week of work in ICU [second time], and lastly two weeks after departure from shift duties [third time].	four weeks for each participant.
Primary	determine stress hormones in serum cortisol and copeptin	Second to determine stress hormones copeptin and cortisol (possible stress biomarkers) concurrently with questionnaire.	four weeks for each participant..
Secondary	correlation of psychological stress with stress hormone copeptin	correlate the level of psychological stress calculated from provided questionnaire in the three assemblies with stress biomarkers copeptin and cortisol in the three measurements.	four weeks for each participant..