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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Heart Rate Variability for Prediction of Perioperative Events

NCT00481234

Anesthesia Coronary Heart Disease

COMPLETED

Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)

NCT01755910

Breast Surgery Thoracic Paravertebral Block HRV +1 more

UNKNOWN

Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers

NCT02264262

Sympathetic Nerve Activity

COMPLETED NA

Heart Rate Variability (HRV) in Patients With Neurogenic Detrusor Overactivity (NDO) Before and After Botulinum Neurotoxin Type A (BoNT/A) Intradetrusor Injections

NCT01337024

Bladder Disorder, Neurogenic

COMPLETED

Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

NCT04229589

Syncope

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autonomic Dysfunction Autonomic Imbalance Blood Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blood donors

Healhy young male bloddonors, aged 30-45

Monitoring of the autonomic nervous system

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Monitoring of the autonomic nervous system

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes