Autonomic Cardiovascular Control in Response to Blood Volume Reduction in Blood Donors
- Conditions
- Autonomic DysfunctionBlood LossAutonomic Imbalance
- Interventions
- Device: Monitoring of the autonomic nervous system
- Registration Number
- NCT04499664
- Lead Sponsor
- Hvidovre University Hospital
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
- Volonteers eligable for blood donation following the Danish legislation
- Male
- Age 30-45
- Written informed consent
- Speak and understand Danish
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Blood donors Monitoring of the autonomic nervous system Healhy young male bloddonors, aged 30-45
- Primary Outcome Measures
Name Time Method Changes in root mean square of successive NN-interval differences (RMSSD) during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms
- Secondary Outcome Measures
Name Time Method Changes in low frequency (LF) power during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms\^2
Changes in low frequency (LF) power during sleep The night before and night after blood donation Measured in ms\^2
Changes high frequency (HF) power during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms\^2
Changes high frequency (HF) power during sleep The night before and night after blood donation Measured in ms\^2
Changes in ratio of LF-to-HF power during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in %
Changes in ratio of LF-to-HF power during sleep The night before and night after blood donation Measured in %
Changes in root mean square of successive NN-interval differences (RMSSD) during sleep The night before and night after blood donation Measured in ms
Changes in standard deviation of N-N intervals (SDNN) during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms
Changes in standard deviation of N-N intervals (SDNN) during sleep The night before and night after blood donation Measured in ms
Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in %
Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during sleep The night before and night after blood donation Measured in %
Changes in S (area of the ellipse which represents total HRV) during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms
Changes in S (area of the ellipse which represents total HRV) during sleep The night before and night after blood donation Measured in ms
Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms
Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during sleep The night before and night after blood donation Measured in ms
Changes in SD2 (Poincaré plot standard deviation along the line of identity) during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms
Changes in SD2 (Poincaré plot standard deviation along the line of identity) during sleep The night before and night after blood donation Measured in ms
Changes in SD1/SD2 ratio during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in ms
Changes in SD1/SD2 ratio during sleep The night before and night after blood donation Measured in ms
Changes in systolic arterial pressure (SAP) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in mmHg by non-invasive LiDCO
Changes in diastolic arterial pressure (DAP) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in mmHg by non-invasive LiDCO
Changes in mean arterial pressure (MAP) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in mmHg by non-invasive LiDCO
Changes in pulse pressure (PP) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in mmHg by non-invasive LiDCO
Changes in heart rate (HR) during mobilisation 15 minutes prior to and 15 minutes after blood donation Measured in beats min-1 by non-invasive LiDCO
Changes in cardiac output (CO) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in L/min by non-invasive LiDCO
Changes in stroke volume (SV) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in mL by non-invasive LiDCO
Changes in systemic vascular resistance (SVR) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in dynes s cm-5 by non-invasive LiDCO
Changes in cerebral perfusion (ScO2) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in % by Root Masimo
Changes in muscular perfusion (SmO2) during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in % by Root Masimo
Changes in peripheral index during mobilization 15 minutes prior to and 15 minutes after blood donation Measured in % by Root Masimo
Concentration of C-reacitve protein At time of blood donation Measured in gr/dL
V-PLEX Biomarker 54.Plex Kit 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
Trial Locations
- Locations (1)
Hvidovre University Hospital
🇩🇰Copenhagen, Denmark