Autonomic Cardiovascular Control in Response to Blood Volume Reduction in Blood Donors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Blood donors Healhy young male bloddonors, aged 30-45 |
Device: Monitoring of the autonomic nervous system
Monitoring of the autonomic nervous system using E-patch, LiDCO and Root-Massimo.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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
Other Outcome Measures
- Pain score [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Volonteers eligable for blood donation following the Danish legislation
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Male
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Age 30-45
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Written informed consent
-
Speak and understand Danish
Exclusion Criteria:
Volonteers not eligable for blood donation following the Danish legislation, among others due to:
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Alcohol and drug abuse
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Cognitive dysfunction
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Use of anxiolytic or antipsychotic drugs
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Arrhythmias or heart failure
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Diabetes mellitus type I
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Diabetes mellitus type II
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Use of opioids
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History of following diseases in the autonomic nervous system: Parkinson disease, multiple sclerosis, autonomic neuropathies
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History of cerebral apoplexy or transitory cerebral ischemia
-
Dementia
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American Society of Anesthesiologists (ASA) score ≥ 4
Furthermore:
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History of orthostatic intolerance and/or orthostatic hypotension
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hvidovre University Hospital | Copenhagen | Denmark | 2960 |
Sponsors and Collaborators
- Hvidovre University Hospital
Investigators
- Study Director: Henrik Kehlet, Professor, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-19069845