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AzTrials

Autonomic DysfunctionNCT04499664

Autonomic Cardiovascular Control in Response to Blood Volume Reduction in Blood Donors

An observational study of Autonomic Dysfunction and Autonomic Imbalance, run by Hvidovre University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The function of the autonomic nervous system can be assessed using baroreflex sensitivity (BRS) and heart rate variability (HRV). Decreased HRV has been shown to be predictive of morbidity and mortality in diverse medical conditions such as acute myocardial infarction, aneurysmal subarachnoid haemorrhage, autoimmune… Read more about this study

Who is it for?
Ages 30 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
Monitoring of the autonomic nervous system
Type of treatment
Medical device
How many people
25 participants
Where
1 siteDenmark
Study dates
1 Aug 2020to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Study population: Healthy male volonteers, aged 30-45, that are eligable for blood donation following the Danish legislation

Who may be able to join

  • Volonteers eligable for blood donation following the Danish legislation
  • Male
  • Age 30-45
  • Written informed consent
  • Speak and understand Danish

Who cannot join

  • Volonteers not eligable for blood donation following the Danish legislation, among others due to:
  • Alcohol and drug abuse
  • Cognitive dysfunction
  • Use of anxiolytic or antipsychotic drugs
  • Arrhythmias or heart failure
  • Diabetes mellitus type I
Show all 16Show fewer
  • Diabetes mellitus type II
  • Use of opioids
  • History of following diseases in the autonomic nervous system: Parkinson disease, multiple sclerosis, autonomic neuropathies
  • History of cerebral apoplexy or transitory cerebral ischemia
  • Dementia
  • American Society of Anesthesiologists (ASA) score ≥ 4
  • Furthermore:
  • History of orthostatic intolerance and/or orthostatic hypotension
  • Use of following vasodilator antihypertensive drugs: beta-blockers, angiotensin converting enzyme inhibitors (ACEI), angiotensin 2 receptor blockers (ARBs), calcium channel blockers
  • Use of loop diuretics, thiazid diuretics and potassium-sparing diuretics

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Hvidovre University Hospital

    Copenhagen, 2960

Other trials in Denmark

About this study

The function of the autonomic nervous system can be assessed using baroreflex sensitivity (BRS) and heart rate variability (HRV). Decreased HRV has been shown to be predictive of morbidity and mortality in diverse medical conditions such as acute myocardial infarction, aneurysmal subarachnoid haemorrhage, autoimmune diseases, sepsis and surgery.

The function of the autonomic nervous system has not yet been investigated in a "pure hypovolemia" model. The aim of the current study is therefore to investigate and describe the function of the autonomic nervous system prior to, during and after reduction of blood volume in healthy blood donors.

Being tested
Monitoring of the autonomic nervous system
Keywords
Heart rate variabilty, Baroreceptor sensitivity, Autonomic nervous system, Acute blood loss, Blood donors, Autonomic cardiovascular control
Medical subject headings
Primary Dysautonomias, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitoring of the autonomic nervous systemDevice

    Monitoring of the autonomic nervous system using E-patch, LiDCO and Root-Massimo.

Study groups in NCT04499664
Study groupRoleWhat they receive
Blood donorsHealhy young male bloddonors, aged 30-45
Receives: Device: Monitoring of the autonomic nervous system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in root mean square of successive NN-interval differences (RMSSD) during mobilisation

    Measured in ms

    Measured: 15 minutes prior to and 15 minutes after blood donation

Secondary outcomes (32)

  1. Changes in root mean square of successive NN-interval differences (RMSSD) during sleep

    Measured in ms

    Measured: The night before and night after blood donation

  2. Changes in standard deviation of N-N intervals (SDNN) during mobilisation

    Measured in ms

    Measured: 15 minutes prior to and 15 minutes after blood donation

  3. Changes in standard deviation of N-N intervals (SDNN) during sleep

    Measured in ms

    Measured: The night before and night after blood donation

  4. Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during mobilisation

    Measured in %

    Measured: 15 minutes prior to and 15 minutes after blood donation

  5. Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during sleep

    Measured in %

    Measured: The night before and night after blood donation

  6. Changes in low frequency (LF) power during mobilisation

    Measured in ms^2

    Measured: 15 minutes prior to and 15 minutes after blood donation

  7. Changes in low frequency (LF) power during sleep

    Measured in ms^2

    Measured: The night before and night after blood donation

  8. Changes high frequency (HF) power during mobilisation

    Measured in ms^2

    Measured: 15 minutes prior to and 15 minutes after blood donation

  9. Changes high frequency (HF) power during sleep

    Measured in ms^2

    Measured: The night before and night after blood donation

  10. Changes in ratio of LF-to-HF power during mobilisation

    Measured in %

    Measured: 15 minutes prior to and 15 minutes after blood donation

  11. Changes in ratio of LF-to-HF power during sleep

    Measured in %

    Measured: The night before and night after blood donation

  12. Changes in S (area of the ellipse which represents total HRV) during mobilisation

    Measured in ms

    Measured: 15 minutes prior to and 15 minutes after blood donation

  13. Changes in S (area of the ellipse which represents total HRV) during sleep

    Measured in ms

    Measured: The night before and night after blood donation

  14. Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during mobilisation

    Measured in ms

    Measured: 15 minutes prior to and 15 minutes after blood donation

  15. Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during sleep

    Measured in ms

    Measured: The night before and night after blood donation

  16. Changes in SD2 (Poincaré plot standard deviation along the line of identity) during mobilisation

    Measured in ms

    Measured: 15 minutes prior to and 15 minutes after blood donation

  17. Changes in SD2 (Poincaré plot standard deviation along the line of identity) during sleep

    Measured in ms

    Measured: The night before and night after blood donation

  18. Changes in SD1/SD2 ratio during mobilisation

    Measured in ms

    Measured: 15 minutes prior to and 15 minutes after blood donation

  19. Changes in SD1/SD2 ratio during sleep

    Measured in ms

    Measured: The night before and night after blood donation

  20. Changes in systolic arterial pressure (SAP) during mobilization

    Measured in mmHg by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  21. Changes in diastolic arterial pressure (DAP) during mobilization

    Measured in mmHg by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  22. Changes in mean arterial pressure (MAP) during mobilization

    Measured in mmHg by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  23. Changes in pulse pressure (PP) during mobilization

    Measured in mmHg by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  24. Changes in heart rate (HR) during mobilisation

    Measured in beats min-1 by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  25. Changes in cardiac output (CO) during mobilization

    Measured in L/min by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  26. Changes in stroke volume (SV) during mobilization

    Measured in mL by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  27. Changes in systemic vascular resistance (SVR) during mobilization

    Measured in dynes s cm-5 by non-invasive LiDCO

    Measured: 15 minutes prior to and 15 minutes after blood donation

  28. Changes in cerebral perfusion (ScO2) during mobilization

    Measured in % by Root Masimo

    Measured: 15 minutes prior to and 15 minutes after blood donation

  29. Changes in muscular perfusion (SmO2) during mobilization

    Measured in % by Root Masimo

    Measured: 15 minutes prior to and 15 minutes after blood donation

  30. Changes in peripheral index during mobilization

    Measured in % by Root Masimo

    Measured: 15 minutes prior to and 15 minutes after blood donation

  31. Concentration of C-reacitve protein

    Measured in gr/dL

    Measured: At time of blood donation

  32. V-PLEX Biomarker 54.Plex Kit

    54 key analytes that are important in inflammation response and immune system regulation as well as numerous other biological processes

    Measured: Blood taken at time of blood donation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Sep 2020
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04499664
Sponsor's protocol ID
H-19069845
Status last verified
Aug 2022
First submitted
31 Jul 2020
Last updated
30 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hristovska AM, Uldall-Hansen B, Mehlsen J, Andersen LB, Kehlet H, Foss NB. Orthostatic intolerance after acute mild hypovolemia: incidence, pathophysiologic hemodynamics, and heart-rate variability analysis-a prospective observational cohort study. Can J Anaesth. 2023 Oct;70(10):1587-1599. doi: 10.1007/s12630-023-02556-6. Epub 2023 Sep 26.

    PubMed 37752379

Questions about this trial

What is this clinical trial studying?

An observational study of Autonomic Dysfunction and Autonomic Imbalance, run by Hvidovre University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in root mean square of successive NN-interval differences (RMSSD) during mobilisation (time frame: 15 minutes prior to and 15 minutes after blood donation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04499664, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.

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