Copeptin and Psychological Stress of Medic During COVID-19 Pandemic

NCT04757285 | Completed

• 1 other identifier: 0304842
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Stress; Hemostatic Disorder

Keywords

psychological stress; copeptin; hormones

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• correlation of psychological stress with stress hormone copeptin

  four weeks for each participant..

Study Arms (2)

control group

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

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.

Eligibility Criteria

• Age: 24 Years - 37 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthcare providers worked in ICU: 35 physicians (28 males and 7 females) and 35 nurses (10 males and 25 females). Age ranged from 24 to 37 years 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. Group Information healthcare providers designated to take duty shifts at ICU in Alexandria quarantine hospitals for two weeks during COVID-19 pandemic. And a control group of healthcare providers not assigned to work in quarantine hospitals. First assembly one day before enrolling to work in ICU. Second assembly at the end of first week of work, third assembly two weeks after departure from work in ICU

You may qualify if:

• physicians and nurses under age of 37 years in good health

You may not qualify if:

• body mass index above 30
• hypertension
• Diabetes mellitus
• females receiving contraceptive pills

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicine

Alexandria, 21311, Egypt

Location

Related Publications (2)

• 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.

  PMID: 17290796 RESULT

• 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.

  PMID: 26794439 RESULT

MeSH Terms

Conditions

Stress, Psychological; Hemostatic Disorders; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Pathology

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 17, 2021
• Study Start: May 10, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)