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

NCT04499664 | Completed

• 1 other identifier: H-19069845
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Dysfunction; Autonomic Imbalance; Blood Loss

Keywords

Heart rate variabilty; Baroreceptor sensitivity; Autonomic nervous system; Acute blood loss; Blood donors; Autonomic cardiovascular control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• Changes in root mean square of successive NN-interval differences (RMSSD) during sleep

  The night before and night after blood donation

• Changes in standard deviation of N-N intervals (SDNN) during mobilisation

  15 minutes prior to and 15 minutes after blood donation

• Changes in standard deviation of N-N intervals (SDNN) during sleep

  The night before and night after blood donation

• 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

• Percentage of successive RR intervals that differ by more than 50 ms (pNN50) during sleep

  The night before and night after blood donation

Other Outcomes (1)

• Pain score

  15 minutes prior to and 15 minutes after blood donation

Study Arms (1)

Blood donors

Healhy young male bloddonors, aged 30-45

Device: Monitoring of the autonomic nervous system

Interventions

Monitoring of the autonomic nervous system DEVICE

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

Blood donors

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy male volonteers, aged 30-45, that are eligable for blood donation following the Danish legislation

You may qualify if:

• Volonteers eligable for blood donation following the Danish legislation
• Male
• Age 30-45
• Written informed consent
• Speak and understand Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Copenhagen, 2960, Denmark

Location

Related Publications (1)

• Hristovska AM, Uldall-Hansen B, Mehlsen J, Andersen LB, Kehlet H, Foss NB. Orthostatic intolerance after acute mild hypovolemia: incidence, pathophysiologic hemodynamics, and heart-rate variability analysis-a prospective observational cohort study. Can J Anaesth. 2023 Oct;70(10):1587-1599. doi: 10.1007/s12630-023-02556-6. Epub 2023 Sep 26.

  PMID: 37752379 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

10 mL of blood stored in a biobank

MeSH Terms

Conditions

Primary Dysautonomias; Hemorrhage

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Kehlet, Professor

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: August 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: June 1, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

DK (1)