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

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499664
• Other study ID #: H-19069845
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 1, 2022
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Imbalance
• Autonomic Nervous System Diseases
• Blood Loss
• Hemorrhage
• Primary Dysautonomias

Intervention

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

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score	Measured by verbal rating scale (VRS) 0 - 10 (0 = no pain, 10 = worse pain imaginable) during mobilisation procedure	15 minutes prior to and 15 minutes after blood donation
Primary	Changes in root mean square of successive NN-interval differences (RMSSD) during mobilisation	Measured in ms	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in root mean square of successive NN-interval differences (RMSSD) during sleep	Measured in ms	The night before and night after blood donation
Secondary	Changes in standard deviation of N-N intervals (SDNN) during mobilisation	Measured in ms	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in standard deviation of N-N intervals (SDNN) during sleep	Measured in ms	The night before and night after blood donation
Secondary	Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during mobilisation	Measured in %	15 minutes prior to and 15 minutes after blood donation
Secondary	Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during sleep	Measured in %	The night before and night after blood donation
Secondary	Changes in low frequency (LF) power during mobilisation	Measured in ms^2	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in low frequency (LF) power during sleep	Measured in ms^2	The night before and night after blood donation
Secondary	Changes high frequency (HF) power during mobilisation	Measured in ms^2	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes high frequency (HF) power during sleep	Measured in ms^2	The night before and night after blood donation
Secondary	Changes in ratio of LF-to-HF power during mobilisation	Measured in %	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in ratio of LF-to-HF power during sleep	Measured in %	The night before and night after blood donation
Secondary	Changes in S (area of the ellipse which represents total HRV) during mobilisation	Measured in ms	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in S (area of the ellipse which represents total HRV) during sleep	Measured in ms	The night before and night after blood donation
Secondary	Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during mobilisation	Measured in ms	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in SD1 (Poincaré plot standard deviation perpendicular the line of identity) during sleep	Measured in ms	The night before and night after blood donation
Secondary	Changes in SD2 (Poincaré plot standard deviation along the line of identity) during mobilisation	Measured in ms	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in SD2 (Poincaré plot standard deviation along the line of identity) during sleep	Measured in ms	The night before and night after blood donation
Secondary	Changes in SD1/SD2 ratio during mobilisation	Measured in ms	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in SD1/SD2 ratio during sleep	Measured in ms	The night before and night after blood donation
Secondary	Changes in systolic arterial pressure (SAP) during mobilization	Measured in mmHg by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in diastolic arterial pressure (DAP) during mobilization	Measured in mmHg by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in mean arterial pressure (MAP) during mobilization	Measured in mmHg by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in pulse pressure (PP) during mobilization	Measured in mmHg by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in heart rate (HR) during mobilisation	Measured in beats min-1 by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in cardiac output (CO) during mobilization	Measured in L/min by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in stroke volume (SV) during mobilization	Measured in mL by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in systemic vascular resistance (SVR) during mobilization	Measured in dynes s cm-5 by non-invasive LiDCO	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in cerebral perfusion (ScO2) during mobilization	Measured in % by Root Masimo	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in muscular perfusion (SmO2) during mobilization	Measured in % by Root Masimo	15 minutes prior to and 15 minutes after blood donation
Secondary	Changes in peripheral index during mobilization	Measured in % by Root Masimo	15 minutes prior to and 15 minutes after blood donation
Secondary	Concentration of C-reacitve protein	Measured in gr/dL	At time of blood donation
Secondary	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	Blood taken at time of blood donation