Clinical trial NCT04499664: Autonomic Cardiovascular Control in Response to Blood Volume Reduction in Blood Donors
Official title: Autonomic Cardiovascular Control in Response to Blood Volume Reduction in Blood Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Dysfunction
Autonomic Imbalance
Blood Loss
Keywords: Heart rate variabilty
Baroreceptor sensitivity
Autonomic nervous system
Acute blood loss
Blood donors
Autonomic cardiovascular control
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 25
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy male volonteers, aged 30-45, that are eligable for blood donation following the Danish legislation

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in root mean square of successive NN-interval differences (RMSSD) during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
Secondary outcomes:
measure: Changes in root mean square of successive NN-interval differences (RMSSD) during sleep
timeFrame: The night before and night after blood donation
measure: Changes in standard deviation of N-N intervals (SDNN) during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in standard deviation of N-N intervals (SDNN) during sleep
timeFrame: The night before and night after blood donation
measure: Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during sleep
timeFrame: The night before and night after blood donation
measure: Changes in low frequency (LF) power during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in low frequency (LF) power during sleep
timeFrame: The night before and night after blood donation
measure: Changes high frequency (HF) power during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes high frequency (HF) power during sleep
timeFrame: The night before and night after blood donation
measure: Changes in ratio of LF-to-HF power during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in ratio of LF-to-HF power during sleep
timeFrame: The night before and night after blood donation
measure: Changes in S (area of the ellipse which represents total HRV) during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in S (area of the ellipse which represents total HRV) during sleep
timeFrame: The night before and night after blood donation
measure: Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during sleep
timeFrame: The night before and night after blood donation
measure: Changes in SD2 (Poincaré plot standard deviation along the line of identity) during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in SD2 (Poincaré plot standard deviation along the line of identity) during sleep
timeFrame: The night before and night after blood donation
measure: Changes in SD1/SD2 ratio during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in SD1/SD2 ratio during sleep
timeFrame: The night before and night after blood donation
measure: Changes in systolic arterial pressure (SAP) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in diastolic arterial pressure (DAP) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in mean arterial pressure (MAP) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in pulse pressure (PP) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in heart rate (HR) during mobilisation
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in cardiac output (CO) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in stroke volume (SV) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in systemic vascular resistance (SVR) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in cerebral perfusion (ScO2) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in muscular perfusion (SmO2) during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Changes in peripheral index during mobilization
timeFrame: 15 minutes prior to and 15 minutes after blood donation
measure: Concentration of C-reacitve protein
timeFrame: At time of blood donation
measure: V-PLEX Biomarker 54.Plex Kit
timeFrame: Blood taken at time of blood donation
Other outcomes:
measure: Pain score
timeFrame: 15 minutes prior to and 15 minutes after blood donation
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, Professor
role: STUDY_DIRECTOR
References: