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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04499664
Other study ID # H-19069845
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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