Copeptin and Psychological Stress of Medic During COVID-19 Pandemic

NCT ID: NCT04757285

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-10
• Study Completion Date: 2020-10-30

Brief 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.

Detailed 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.

Conditions

Psychological Stress; Hemostatic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

control group

25 healthcare personnel volunteers not working in quarantine hospitals of matched age

No interventions assigned to this group

healthcare providers worked in Intensive Care Units

35 physicians (28 males and 7 females) and 35 nurses (10 males and 25 females). All volunteers were 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.

Assigned participants were clinically evaluated for as hypertension, DM, dyslipidemia, renal function.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

hala mourad demerdash

Consultant Clinical Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alexandria University Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

References

McEwen BS. Protective and damaging effects of stress mediators: central role of the brain. Dialogues Clin Neurosci. 2006;8(4):367-81. doi: 10.31887/DCNS.2006.8.4/bmcewen.

Reference Type: RESULT

PMID: 17290796 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26794439 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0304842

Identifier Type: -

Identifier Source: org_study_id