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Completed

NCT Number: NCT04499664

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

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.

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Key information

Conditions

Autonomic Dysfunction Autonomic Imbalance Autonomic Nervous System Diseases Blood Loss Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Dysautonomias

Age range

30 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Hvidovre University Hospital

Copenhagen, 2960, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
  • 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

Treatment and study plan

Monitoring of the autonomic nervous system

Device

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

Primary outcomes

  1. 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

    Measured in ms

Secondary outcomes

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

    Time frame: The night before and night after blood donation

    Measured in ms

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in ms

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

    Time frame: The night before and night after blood donation

    Measured in ms

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in %

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

    Time frame: The night before and night after blood donation

    Measured in %

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in ms^2

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

    Time frame: The night before and night after blood donation

    Measured in ms^2

  8. Changes high frequency (HF) power during mobilisation

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in ms^2

  9. Changes high frequency (HF) power during sleep

    Time frame: The night before and night after blood donation

    Measured in ms^2

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in %

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

    Time frame: The night before and night after blood donation

    Measured in %

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in ms

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

    Time frame: The night before and night after blood donation

    Measured in ms

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in ms

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

    Time frame: The night before and night after blood donation

    Measured in ms

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in ms

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

    Time frame: The night before and night after blood donation

    Measured in ms

  18. Changes in SD1/SD2 ratio during mobilisation

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in ms

  19. Changes in SD1/SD2 ratio during sleep

    Time frame: The night before and night after blood donation

    Measured in ms

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in mmHg by non-invasive LiDCO

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in mmHg by non-invasive LiDCO

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in mmHg by non-invasive LiDCO

  23. Changes in pulse pressure (PP) during mobilization

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in mmHg by non-invasive LiDCO

  24. Changes in heart rate (HR) during mobilisation

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in beats min-1 by non-invasive LiDCO

  25. Changes in cardiac output (CO) during mobilization

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in L/min by non-invasive LiDCO

  26. Changes in stroke volume (SV) during mobilization

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in mL by non-invasive LiDCO

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

    Time frame: 15 minutes prior to and 15 minutes after blood donation

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

  28. Changes in cerebral perfusion (ScO2) during mobilization

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in % by Root Masimo

  29. Changes in muscular perfusion (SmO2) during mobilization

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in % by Root Masimo

  30. Changes in peripheral index during mobilization

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured in % by Root Masimo

  31. Concentration of C-reacitve protein

    Time frame: At time of blood donation

    Measured in gr/dL

  32. V-PLEX Biomarker 54.Plex Kit

    Time frame: Blood taken at time of blood donation

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

Other outcomes

  1. Pain score

    Time frame: 15 minutes prior to and 15 minutes after blood donation

    Measured by verbal rating scale (VRS) 0 - 10 (0 = no pain, 10 = worse pain imaginable) during mobilisation procedure

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Aug 5, 2020
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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